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144 Study Matches
Genome Transplant Dynamics (GTD NIH)
Sean T Agbor-Enoh, M.D. - agborenohst@mail.nih.gov
Shah, Keyur, B
NCT02423070
HM20004684
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* INCLUSION CRITERIA:
* Lung and heart transplant candidates. Dual organ transplants such as those that include lung or heart PLUS any other organ are also considered for enrollment.
* Subjects who have undergone lung or heart transplants and are within 3 months of transplantation.
* 14 years and older
* Able to understand and be willing to sign the informed consent form. Subjects undergoing a double transplant will sign a single consent.
* Retransplant candidates will be considered as a new transplants. These subjects will be approached for enrollment and if they consent to participate, they will be assigned a different SSPIN.
EXCLUSION CRITERIA:
-Pregnancy
Thoracic Organ Transplantation
Cell-free DNA, Acute Rejection, Thoracic Organ Transplantation, Non-Invasive Testing, Chronic Rejection, Natural History
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Study Locations
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| Location | Contacts |
|---|---|
| INOVA Fairfax Medical Falls Church, Virginia | Steven Nathan, M.D. - (steven.nathan@inova.org) |
| Johns Hopkins University Baltimore, Maryland | Jonathan Orens, M.D. - (jorens@jhmi.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| National Institutes of Health Clinical Center Bethesda, Maryland | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) - (ccopr@nih.gov) |
| University of Maryland Baltimore, Maryland | |
| Virginia Commonwealth University Richmond, Virginia |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Lisa Erickson, MPH - 10-CBA@ndmp.org
McCarty, John, M.
NCT01351545
HM13913
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Inclusion Criteria:
* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
* Pediatric and adult patients of any age
Exclusion Criteria:
* Patients who are receiving only licensed CBUs
* Cord blood transplant recipients at international transplant centers
* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated DRUG: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia
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Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Rushang Patel, MD - (rushang.patel.md@adventhealth.com) |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| All Children's Hospital St. Petersburg, Florida | Deepakbabu Chellapandian, MD - (dchella2@jhmi.edu) |
| Amarillo Blood and Marrow Transplant Program Amarillo, Texas | |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Sonali Chaudhury, MD - (schaudhury@luriechildrens.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | Jason Farrar, MD - (JEFarrar@uams.edu) |
| Avera Transplant Institute Sioux Falls, South Dakota | Waqas Jehangir, MD, FACP - (waqas.jehangir@avera.org) |
| Banner MD Anderson Cancer Center Gilbert, Arizona | September Mitchell, RN - (september.mitchell@bannerhealth.com) Rajneesh Nath, MD - (rajneesh.nath@bannerhealth.com) |
| Beth Israel Deaconess Boston, Connecticut | |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | Deepika Bhatla, MD - (dbhatla@slu.edu) |
| Children's Healthcare of Atlanta Atlanta, Georgia | Ann Haight, MD - (Ann.haight@choa.org) |
| Children's Hospital Colorado Aurora, Colorado | Michael Verneris, MD - (MICHAEL.VERNERIS@CUANSCHUTZ.EDU) |
| Children's Hospital and Research Center of Oakland Oakland, California | Mark Walters, MD - (mwalters@mail.cho.org) |
| Children's Hospital at Montefiore The Bronx, New York | Mahvish Rahim, MD - (mrahim@montefiore.org) |
| Children's Hospital of Los Angeles Los Angeles, California | Neena Kapoor, MD - (nkapoor@chla.usc.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Sureyya Savasan, MD - (ssavasan@med.wayne.edu) |
| Children's Hospital of New Orleans/LSUHSC New Orleans, Louisiana | Lolie Yu, MD - (lyu@lsuhsc.edu) |
| Children's Hospital of Orange County (CHOC) Orange, California | Rishikesh Chavan, MD - (rishikesh.chavan@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Nancy Bunin, MD - (buninn@email.chop.edu) |
| Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | Paul Szabolcs, MD - (Paul.szabolcs@chp.edu) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | David Margolis, MD - (dmargoli@mcw.edu) |
| Children's Medical Center Dallas Dallas, Texas | Victor Aquino, MD - (Victor.aquino@utsouthwestern.edu) |
| Children's Mercy Hospital and Clinics Kansas City, Missouri | |
| Children's National Medical Center Washington D.C., District of Columbia | David Jacobsohn, MD - (dajacobs@childrensnational.org) |
| Childrens Hospital Medical Center of Akron Akron, Ohio | Megan Sampson, MD - (msampson@akronchildrens.org) |
| Cincinnati Children's Hospital Cincinnati, Ohio | Stella Davies, MD - (stella.davies@cchmc.org) |
| City of Hope Duarte, California | Monzr Al Malki, MD - (malmalki@coh.org) |
| Cleveland Clinic Cleveland, Ohio | Craig Sauter, MD - (sauterc@ccf.org) |
| Cohen Children's Medical Center of New York New Hyde Park, New York | Jonathan Fish, MD - (jfish1@nshs.edu) |
| Columbia University Medical Center - Morgan Stanley Children's Hospital New York, New York | Monica Bhatia, MD - (mb2476@columbia.edu) |
| Cook Children's Hospital Fort Worth, Texas | Gretchen Eames, MD - (gretchen.eames@cookchildrens.org) |
| Dana Farber Cancer Institute Boston, Massachusetts | Corey Cutler, MD - (cscutler@partners.org) |
| Duke University Medical Center Durham, North Carolina | Joanne Kurtzberg, MD - (kurtz001@mc.duke.edu) |
| Emory University Hospital Atlanta, Georgia | |
| Florida Center for Pediatric Cellular Therapy Orlando, Florida | Susan Kelly, MD - (susan.kelly.md@flhosp.org) |
| Fred Hutchinson Cancer Research Center Seattle, Washington | Ann Dahlberg, MD - (adahlber@fredhutch.org) |
| Greenebaum Cancer Center - University of Maryland Baltimore, Maryland | |
| H Lee Moffitt Cancer Center Tampa, Florida | |
| Hackensack University Medical Center Hackensack, New Jersey | Alfred Gillio, MD - (agillio@humed.com) |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | Troy Quigg, MD - (troy.quigg@spectrumhealth.org) |
| Henry Ford Health System Detroit, Michigan | Nalini Janakiraman, MD - (njanaki1@hfhs.org) |
| Indiana Blood & Marrow Transplantation Beech Grove, Indiana | Luke Akard, MD - (lakard@ibmtindy.com) |
| Indiana University/Riley Hospital for Children Indianapolis, Indiana | Jodi Skiles, MD - (jskiles@iu.edu) |
| Johns Hopkins Baltimore, Maryland | Allen Chen, MD, PhD - (allenchen@jhmi.edu) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | Randal Wada, MD - (randalw@hawaii.edu) |
| Karmanos Cancer Institute Detroit, Michigan | |
| Levine Children's Hospital Charlotte, North Carolina | Jeffrey Huo, MD - (Jeffrey.Huo@carolinashealthcare.org) Michelle Hyland - (Michelle.Hyland@carolinashealthcare.org) |
| Loma Linda University Cancer Center Loma Linda, California | Hisham Abdel-Azim, MD - (habdelazim@llu.edu) |
| Loyola University Medical Center Maywood, Illinois | Patrick Stiff, MD - (pstiff@lumc.edu) |
| M.D. Anderson Cancer Center Houston, Texas | Elizabeth Shpall, MD - (eshpall@mdanderson.org) |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | Vivek Roy, MD - (roy.vivek@mayo.edu) |
| Mayo Clinic Arizona (adults) Phoenix, Arizona | James Slack, MD - (slack.james@mayo.edu) |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Medical City Dallas Dallas, Texas | Vikas Bhushan, MD - (vikas.bhushan@usoncology.com) |
| Medical College of Georgia Augusta, Georgia | Claude Sportes, MD - (csportes@gru.edu) |
| Medical College of Wisconsin Milwaukee, Wisconsin | Hamadani Mehdi, MD - (mhamadani@mcw.edu) |
| Medical University of South Carolina Charleston, South Carolina | Michelle Hudspeth, MD - (hudspeth@musc.edu) |
| Memorial Sloan-Kettering Cancer Center New York, New York | Ioannis Politikos, MBBS - (politiki@mskcc.org) |
| Methodist Healthcare Blood and Marrow Transplant Center Memphis, Tennessee | Fnu Kaweeta, MD - (fnu.kaweeta@mlh.org) Joshua Boss, RN - (fnu.kaweeta@westclinic.com) |
| Methodist Healthcare System of San Antonio/Texas Transplant Institute San Antonio, Texas | Jose Cruz, MD - (josecarlos.cruz@hcahealthcare.com) |
| Midwestern Regional Medical Center Zion, Illinois | |
| Mount Sinai Medical Center Miami Beach, Florida | Alla Keyzner, MD - (alla.keyzner@mssm.edu) |
| NIH/NCI Bethesda, Maryland | |
| Nationwide Children's Hospital Columbus, Ohio | Rolla Abu-Arja, MD - (rolla.abu-arja@nationwidechildrens.org) |
| Nemours - Alfred I. duPont Hospital for Children Brandywine, Delaware | Emi Caywood, MD - (ecaywood@nemours.org) |
| Nemours Children's Hospital - Mayo Jacksonville Jacksonville, Florida | Michael Joyce, MD - (mjoyce@nemours.org) |
| New York Presbyterian Hospital at Cornell New York, New York | Tsiporah Shore, MD - (tbs2001@med.cornell.edu) |
| New York University Langone Medical Center New York, New York | A. Samer Al-Homsi, MD - (Samer.Al-Homsi@nyumc.org) Kelli Cole - (Kelli.cole@nyumc.org) |
| Nih/Nhlbi Bethesda, Maryland | Richard Childs, MD - (childsr@nih.gov) |
| Nih/Niaid Bethesda, Maryland | Elizabeth Kang, MD - (ekang@niaid.nih.gov) |
| Niklaus Children's Hospital Miami, Florida | Jorge Galvez-Silva, MD - (jorgericardo.galvezsilva@nicklaushealth.org) |
| North Shore University Hospital Manhasset, New York | Ruthee L Bayer, MD - (rbayer@nshs.edu) |
| Northside Hospital Atlanta, Georgia | Scott Solomon, MD - (ssolomon@bmtga.com) |
| Northwestern Memorial Hospital Chicago, Illinois | Kehinde Adekola, MD - (kehinde-adekola@northwestern.edu) |
| Oregon Health & Science University/Doernbecher Children's Hospital Portland, Oregon | Eneida Nemecek, MD - (nemeceke@ohsu.edu) |
| Orlando Health Bone Marrow Transplant and Cellular Therapy Orlando, Florida | Yasser Khaled, MD - (yasser.khaled@orlandohealth.com) |
| Penn State Milton S. Hershey Cancer Center Hershey, Pennsylvania | Shin Mineishi, MD - (smineishi@pennstatehealth.psu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | |
| Presbyterian St. Luke's/Colorado Blood Cancer Institute Denver, Colorado | Alireza Eghtedar, MD - (alireza.eghtedar@healthonecares.com) |
| Rady Children's Hospital San Diego San Diego, California | Eric Anderson, MD - (eanderson@rchsd.org) |
| Robert Wood Johnson/Cancer Institute of New Jersey New Brunswick, New Jersey | Matthew Matasar, MD, MS - (mm3511@cinj.rutgers.edu) |
| Roger Williams Medical Center Providence, Rhode Island | Todd Roberts, MD - (todd.roberts@chartercare.org) |
| Roswell Park Cancer Institute Buffalo, New York | Philip McCarthy, MD - (philip.mccarthy@roswellpark.org) |
| Rush University Medical Center Chicago, Illinois | |
| Sarah Cannon BMT Program Nashville, Tennessee | |
| Scripps Green Hospital La Jolla, California | Jeffrey W Andrey, MD - (andrey.jeffrey@scrippshealth.org) |
| Southwest Cancer Treatment & Research Center Lubbock, Texas | |
| Spectrum Health Grand Rapids, Michigan | Aly Abdel-Mageed, MD - (aly.mageed@helendevoschildrens.org) |
| St. Jude Childrens Research Hospital Memphis, Tennessee | Renee Madden, MD - (renee.madden@stjude.org) |
| St. Louis University Medical Center St. Louis, Missouri | Sagun Goyal, MD - (sgoyal3@slu.edu) |
| Stanford University Medical Center Palo Alto, California | Andrew Rezvani, MD - (arezvani@stanford.edu) |
| Stony Brook University Hospital Stony Brook, New York | Michael Schuster, MD - (mschuster@notes.cc.sunysb.edu) |
| Strong Memorial Hospital/University of Rochester Rochester, New York | Omar Aljitawi, MD - (omar_aljitawi@urmc.rochester.edu) |
| Sutter Medical Center Sacramento, California | Michael Carroll, MD - (carrolmp@sutterhealth.org) |
| Texas Children's Hospital - Baylor Medical Center Houston, Texas | Robert Krance, MD - (rakrance@txch.org) |
| The Arthur G. James Cancer Hospital/The Ohio State University Medical Center Columbus, Ohio | Sumithira Vasu, MD - (sumithira.vasu@osumc.edu) |
| The Children's Hospital of San Antonio San Antonio, Texas | Martin Andreansky, MD, PhD - (martin.andreansky@bcm.edu) Mark Schambura - (Mark.schambura@christushealth.org) |
| The Jewish Hospital Cincinnati, Ohio | |
| Tufts Medical Center Boston, Massachusetts | Andreas Klein, MD - (aklein2@tuftsmedicalcenter.org) |
| Tulane Medical Center New Orleans, Louisiana | Hana Safa, MD - (hsafah@tulane.edu) |
| UCLA Los Angeles, California | Gary Schiller, MD - (gschiller@mednet.ucla.edu) |
| UCSF (adults) San Francisco, California | |
| UCSF (peds) San Francisco, California | |
| Univeristy of Mississippi Medical Center Jackson, Mississippi | Carolyn Bigelow, MD - (cbigelow@umc.edu) |
| University Hospitals Case Medical Center Cleveland, Ohio | Hillard Lazarus, MD - (hillard.lazarus@case.edu) |
| University of Alabama at Birmingham Birmingham, Alabama | Joseph Chewning, MD - (jchewning@peds.uab.edu) |
| University of Arizona Medical Center - Tucson Tucson, Arizona | Emmanuel Katsanis, MD - (katsanis@peds.arizona.edu) |
| University of California San Diego La Jolla, California | Edward Ball, MD - (tball@ucsd.edu) |
| University of Chicago Chicago, Illinois | James LaBelle, MD, PhD - (jlabelle@peds.bsd.uchicago.edu) |
| University of Colorado Hospital Aurora, Colorado | Jonathan Gutman, MD - (jonathan.gutman@ucdenver.edu) |
| University of Florida Shands Medical Center Gainesville, Florida | Jordan Milner, MD - (jordan.milner@ufl.edu) |
| University of Illinois at Chicago Chicago, Illinois | Damiano Rondelli, MD - (drond@uic.edu) |
| University of Iowa Iowa City, Iowa | Margarida Silverman, MD - (margarida-silverman@uiowa.edu) |
| University of Kansas Kansas City, Kansas | Joseph McGuirk, DO - (jmcguirk@kumc.edu) |
| University of Louisville Hospital - James Brown Cancer Center Louisville, Kentucky | William Tse, MD - (w0tse002@louisville.edu) |
| University of Massachusetts Worcester, Massachusetts | Jan Cerny, MD - (Jan.Cerny@umassmemorial.org) |
| University of Miami (adult) Miami, Florida | |
| University of Miami (peds) Miami, Florida | |
| University of Michigan Ann Arbor, Michigan | Jessica Yu - (jjxyu@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Phyllis Warkenton, MD - (pwarkent@unmc.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| University of Oklahoma Health Science Center Oklahoma City, Oklahoma | Adam Asch, MD - (adam-asch@ouhsc.edu) |
| University of Pennsylvania/Thomas Jefferson Pittsburg, Pennsylvania | Elizabeth Hexner, MD - (elizabeth.hexner@uphs.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Alison Sehgal, MD - (sehgalar@upmc.edu) |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Utah Salt Lake City, Utah | Ahmad Rayes, MD - (ahmad.rayes@hsc.utah.edu) |
| University of Virginia Charlottesville, Virginia | Karen Ballen, MD - (KB3TC@hscmail.mcc.virginia.edu) |
| University of Wisconsin - Madison Madison, Wisconsin | Kenneth DeSantes, MD - (kbdesantes@pediatrics.wisc.edu) |
| VA Puget Sound HCS Seattle, Washington | |
| VA Tennessee Valley Healthcare System Nashville, Tennessee | |
| Vanderbilt University Nashville, Tennessee | Michael Byrne, MD - (michael.byrne@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | John McCarty, MD - (jmccarty@vcu.edu) |
| Wake Forest University Winston-Salem, North Carolina | |
| Washington University St. Louis St Louis, Missouri | Geoffrey Uy, MD - (guy@wustl.edu) |
| Washington University/St. Louis Children's Hospital St Louis, Missouri | Geoffrey Uy, MD - (guy@wustl.edu) |
| West Virginia University Morgantown, West Virginia | Lauren Veltri, MD - (lveltri@hsc.wvu.edu) |
| Westchester Medical Center Valhalla, New York | Mitchell Cairo, MD - (mitchell_cairo@nymc.edu) |
| Western Penn Hospital Pittsburg, Pennsylvania | John Lister, MD - (Jlister@wpahs.org) |
| Yale New Haven Hospital New Haven, Connecticut | Aaron Flagg, MD - (aron.flagg@yale.edu) |
| Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center) Fort Sam Houston, Texas | Bradley Beeler, MD - (bradley.w.beeler.mil@health.mil) |
Multi-Center African-American Inflammatory Bowel Disease Study (MAAIS) (MAAIS)
Lisa Datta, MS - ibd@jhu.edu
Kuemmerle, John, F
NCT01169194
HM12998
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Inclusion Criteria:
• African Americans with a confirmed diagnosis of Inflammatory Bowel Disease (IBD)
• African Americans without a diagnosis of IBD and without a family history of IBD for comparison purposes
Exclusion Criteria:
Patients whose IBD cannot be confirmed
Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, IBD, CD, UC, IC, African American IBD, African American CD, African American UC, African American IC, Black IBD, Black CD, Black UC, Black IC, African American Inflammatory Bowel Disease, African American Crohn's Disease, African American Ulcerative Colitis, African American Indeterminate Colitis, Black Inflammatory Bowel Disease, Black Crohn's Disease, Black Ulcerative Colitis, Black Indeterminate Colitis
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Study Locations
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| Location | Contacts |
|---|---|
| Baylor College of Medicine Houston, Texas | Jullia Guardado - (jguardad@bcm.edu) |
| Johns Hopkins University School Of Medicine Baltimore, Maryland | Lisa Datta, MS - (ibd@jhu.edu) |
| Robert Wood Johnson Medical School New Brunswick, New Jersey | - (IBD_genetics@rwjms.rutgers.edu) |
| University of Alabama at Birmingham Birmingham, Alabama | Angelia Johnson - (angeliagjohnson@uabmc.edu) |
| University of Chicago Chicago, Illinois | Kristi Kearney, RN - (kkearney@medicine.bsd.uchicago.edu) |
| University of Louisville Louisville, Kentucky | Susie Mann, LPN - (suzanne.mann@louisville.edu) |
| University of Maryland Baltimore/University of Maryland Medical System Baltimore, Maryland | Elaine Puppa, RN - (eleonard@peds.umaryland.edu) |
| University of North Carolina Chapel Hill Chapel Hill, North Carolina | Susan Jackson, MPA - (Susan_jackson@med.unc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Jay Kuemmerle - (john.kuemmerle@vcuhealth.org) |
| Weill Cornell Medical College New York, New York | Fatiha Chabouni - (fac2005@med.cornell.edu) |
Project: Every Child for Younger Patients With Cancer (EVERYCHILD)
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Massey, Gita, V.
NCT02402244
HM20006485
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Inclusion Criteria:
* Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem
* Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority
* Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
* All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one "1" (borderline), two "2" (carcinoma in situ) or three "3" (malignant)
* All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
* All neoplastic lesions of the kidney regardless of behavior, i.e., benign, borderline or malignant
* The following other benign/borderline conditions:
* Mesoblastic nephroma
* Teratomas (mature and immature types)
* Myeloproliferative diseases including transient myeloproliferative disease
* Langerhans cell histiocytosis
* Lymphoproliferative diseases
* Desmoid tumors
* Gonadal stromal cell tumors
* Neuroendocrine tumors including pheochromocytoma
* Melanocytic tumors, except clearly benign nevi
* Ganglioneuromas
* Subjects must be =\< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network \[NCTN\]) therapeutic study, for which there is a higher upper age limit
* All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission
* If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1 OTHER: Cytology Specimen Collection Procedure, OTHER: Medical Chart Review
Adrenal Gland Pheochromocytoma, Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Kidney Neoplasm, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid Fibromatosis, Ganglioneuroma, Lymphoproliferative Disorder, Malignant Neoplasm, Malignant Solid Neoplasm, Melanocytic Neoplasm, Myeloproliferative Neoplasm, Neoplasm of Uncertain Malignant Potential, Neuroendocrine Neoplasm, Stromal Neoplasm
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Show 242 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Brooke Army Medical Center Fort Sam Houston, Texas | |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | Site Public Contact - (CHResearch@lcmchealth.org) |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| Hurley Medical Center Flint, Michigan | |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| King Faisal Specialist Hospital and Research Centre Riyadh, | |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (sverwys@mmc.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Monash Medical Center-Clayton Campus Clayton, Victoria | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (nr2616@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Naval Medical Center -San Diego San Diego, California | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Northwestern Medicine Central DuPage Hospital Winfield, Illinois | Site Public Contact - (Claudine.Gamster@CadenceHealth.org) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Palms West Radiation Therapy Loxahatchee Groves, Florida | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Princess Margaret Hospital for Children Perth, Western Australia | |
| Prisma Health Richland Hospital Columbia, South Carolina | |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Royal Children's Hospital Parkville, Victoria | Site Public Contact - (Jordan.Hansford@rch.org.au) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Sacred Heart Hospital Pensacola, Florida | Site Public Contact - (eebrou@ascension.org) |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| San Jorge Children's Hospital San Juan, | |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Saskatoon Cancer Centre Saskatoon, | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | Site Public Contact - (pridgely@lifebridgehealth.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Starship Children's Hospital Auckland, | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (NCIclinicaltrials@sutterhealth.org) |
| Sydney Children's Hospital Randwick, New South Wales | |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tripler Army Medical Center Honolulu, Hawaii | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (Carla.Golden@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vannie Cook Children's Clinic McAllen, Texas | Site Public Contact - (jrhartl1@txch.org) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | |
| West Michigan Cancer Center Kalamazoo, Michigan | |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Women's and Children's Hospital-Adelaide North Adelaide, South Australia | Site Public Contact - (cywhs.oncsec@health.sa.gov.au) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Massey, Gita, V.
NCT00904241
HM1538
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Inclusion Criteria:
* All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study
* There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype
* Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and procurement of study-related tissues with the following exception:
* Patients that in the opinion of the treating physician are too ill to undergo pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on ANBL00B1; documentation of the emergent nature of therapy initiation is required
* It is required that a good faith effort (documented by specimen tracking) be made to submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow) of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be obtained prior to initiation of therapy
* Exceptions
* In rare cases, patients may be deemed too ill to undergo pre-treatment tissue biopsy and require EMERGENT therapy; the following eligibility guidelines apply to these cases:
* For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g., primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT therapy initiation should be made; however, if the child is deemed too unstable for such a procedure they may still be enrolled as long as pre-treatment peripheral blood and serum have been submitted
* For all other INSS stages: tumor tissue should be obtained as soon as possible within 96 hours of EMERGENT therapy initiation; patients without tumor tissues submitted within this time-frame are not eligible for enrollment
* Note: it may not be possible to obtain all necessary tumor biomarkers for therapy stratification in such cases; if a patient enrolled on ANBL00B1 undergoes an additional diagnostic procedure within 96 hours of initiating therapy, additional tumor specimens may be submitted to obtain biomarkers used for risk classification; the decision to perform such procedures, and/or submit these specimens, is to be made by the managing clinicians and should reflect the clinical need to know the status of such biomarkers
* Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a tumor biopsy or resection upfront; tumor tissue submission is therefore not required for these patients to enroll on ANBL00B1; a peripheral blood and serum sample is the only specimen required to be submitted for this group of patients; should they undergo a biopsy or resection at a later date tumor can be submitted for biomarker testing at this time
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol OTHER: Cytology Specimen Collection Procedure, OTHER: Laboratory Biomarker Analysis
Ganglioneuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma
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Show 259 locations
Study Locations
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| Location | Contacts |
|---|---|
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (dperry@nemours.org) |
| Allan Blair Cancer Centre Regina, Saskatchewan | |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (melissa.leffin@orlandohealth.com) |
| Ascension Saint John Hospital Detroit, Michigan | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beaumont Children's Hospital-Royal Oak Royal Oak, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Brooke Army Medical Center Fort Sam Houston, Texas | |
| Brooklyn Hospital Center Brooklyn, New York | |
| Broward Health Medical Center Fort Lauderdale, Florida | |
| C S Mott Children's Hospital Ann Arbor, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Cardon Children's Medical Center Mesa, Arizona | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Carilion Clinic Children's Hospital Roanoke, Virginia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | |
| Centre Hospitalier Universitaire de Quebec Québec, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Healthcare of Atlanta - Egleston Atlanta, Georgia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital London, Ontario | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Los Angeles Los Angeles, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Medical Center Of Akron Akron, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital New Orleans New Orleans, Louisiana | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital and Research Center at Oakland Oakland, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Columbia Regional Columbia, Missouri | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Dayton Children's Hospital Dayton, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| East Tennessee State University Johnson City, Tennessee | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Eastern Maine Medical Center Bangor, Maine | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Floating Hospital for Children at Tufts Medical Center Boston, Massachusetts | |
| Florida Hospital Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Greenville Cancer Treatment Center Greenville, South Carolina | |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Henry Ford Hospital Detroit, Michigan | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (jason.mcguire@sickkids.ca) |
| Hurley Medical Center Flint, Michigan | |
| IWK Health Centre Halifax, Nova Scotia | |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente Washington Seattle, Washington | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kalamazoo Center for Medical Studies Kalamazoo, Michigan | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| King Faisal Specialist Hospital and Research Centre Riyadh, | |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (prmc.coordinator@nyumc.org) |
| Lee Memorial Health System Fort Myers, Florida | |
| Legacy Emanuel Children's Hospital Portland, Oregon | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Legacy Emanuel Hospital and Health Center Portland, Oregon | |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Torrance, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| M D Anderson Cancer Center Houston, Texas | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (mamcdci@amedd.army.mil) |
| Maimonides Medical Center Brooklyn, New York | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Mayo Clinic Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (clayter1@memorialhealth.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Children's Hospital Toledo, Ohio | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Miami Cancer Institute Miami, Florida | Site Public Contact - (cancerinfo@baptisthealth.net) |
| Michigan State University Clinical Center East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Mission Hospital Inc-Memorial Campus Asheville, North Carolina | Site Public Contact - (leslie.verner@msj.org) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (nr2616@cumc.columbia.edu) |
| NYU Winthrop Hospital Mineola, New York | |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Naval Medical Center -San Diego San Diego, California | |
| Nemours Children's Clinic - Orlando Orlando, Florida | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | |
| Nicklaus Children's Hospital Miami, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (nnechiporchik@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Gregory.Johnstone@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Overlook Hospital Summit, New Jersey | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Primary Children's Hospital Salt Lake City, Utah | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Princess Margaret Hospital for Children Perth, Western Australia | |
| Prisma Health Richland Hospital Columbia, South Carolina | |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Queensland Children's Hospital South Brisbane, Queensland | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rady Children's Hospital - San Diego San Diego, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Royal Brisbane and Women's Hospital Brisbane, Queensland | |
| Royal Children's Hospital Parkville, Victoria | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Royal Children's Hospital-Brisbane Herston, Queensland | |
| Rush University Medical Center Chicago, Illinois | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Barnabas Medical Center Livingston, New Jersey | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Mountain States Tumor Institute Boise, Idaho | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Mary's Hospital Rhinelander, Wisconsin | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (Christy.Gilchrist@hshs.org) |
| Saint Vincent Hospital and Health Care Center Indianapolis, Indiana | |
| San Jorge Children's Hospital San Juan, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Saskatoon Cancer Centre Saskatoon, | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Sinai Hospital of Baltimore Baltimore, Maryland | Site Public Contact - (pridgely@lifebridgehealth.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| St. Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Starship Children's Hospital Auckland, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| State University of New York Downstate Medical Center Brooklyn, New York | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sutter Medical Center Sacramento Sacramento, California | Site Public Contact - (cancerinfo@sutterhealth.org) |
| Swiss Pediatric Oncology Group - Bern Bern, | |
| Swiss Pediatric Oncology Group - Geneva Geneva, | |
| Swiss Pediatric Oncology Group - Lausanne Lausanne, | |
| Sydney Children's Hospital Randwick, New South Wales | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| T C Thompson Children's Hospital Chattanooga, Tennessee | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| The Children's Hospital at Westmead Westmead, New South Wales | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio | |
| The University of Arizona Medical Center-University Campus Tucson, Arizona | |
| Tod Children's Hospital - Forum Health Youngstown, Ohio | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| Tripler Army Medical Center Honolulu, Hawaii | |
| Tulane University Health Sciences Center New Orleans, Louisiana | |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | |
| UCSF Medical Center-Parnassus San Francisco, California | |
| UF Cancer Center at Orlando Health Orlando, Florida | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center Groningen Groningen, | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University Pediatric Hospital San Juan, | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (val.taylor@albertahealthservices.ca) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Massachusetts Medical School Worcester, Massachusetts | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (LByatt@nmcca.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Texas Medical Branch Galveston, Texas | Michael D. Hogarty - (HOGARTYM@email.chop.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (PAS9E@virginia.edu) |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | |
| Valley Children's Hospital Madera, California | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (mwellons@vcu.edu) |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | Site Public Contact - (ctoadmin@karmanos.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| William Beaumont Hospital-Royal Oak Royal Oak, Michigan | |
| Women's and Children's Hospital-Adelaide North Adelaide, South Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Pathway to Prevention Study
Memoli, Erica, H - erica.memoli@vcuhealth.org
Nelson, Bryce
NCT00097292
HM20012389
Endocrine, Nutritional And Metabolic Diseases, And Immunity Disorders, Endocrine, Nutritional, Metabolic Diseases, Immunity Disorders (240-279)
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Memoli, Erica, H - (erica.memoli@vcuhealth.org) |
A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)
Ellie Michalski - emichalski@targetrwe.com
Luketic, Velimir, A
NCT02815891
HM20010841
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Inclusion Criteria:
1\. Adults and children (age 2 or older) being managed or treated for nonalcoholic fatty liver disease. Diagnosis is based on the clinical judgement of the care provider.
Exclusion Criteria:
1\. Inability to provide informed assent/consent. Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
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Study Locations
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| Location | Contacts |
|---|---|
| Advanced Gastroenterology Associates, LLC Palm Harbor, Florida | |
| AdventHealth Diabetes Institute Orlando, Florida | |
| Asheville Gastroenterology Associates, PA Asheville, North Carolina | |
| Atlanta Gastroenterology Associates, LLC Atlanta, Georgia | |
| Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic Phoenix, Arizona | |
| Baylor College of Medicine/Texas Children's Hospital Houston, Texas | |
| Bon Secours Liver Institute of Virginia Richmond, Virginia | |
| California Liver Research Institute Pasadena, California | |
| Carteret Medical Group Morehead City, North Carolina | |
| Center for Liver Disease and Transplant at CMC Charlotte, North Carolina | |
| Charite Berlin Berlin, | Markus Reib - (markus.reiss@charite.de) |
| Children's Health - Children's Medical Center Dallas Dallas, Texas | |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| Cleveland Clinic Children's Cleveland, Ohio | |
| Columbia University Medical Center New York, New York | |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Connecticut Gastroenterology Hartford, Connecticut | |
| Digestive Health Specialists, PA Winston-Salem, North Carolina | |
| Duke University Medical Center Durham, North Carolina | |
| Emory University - Children's Healthcare of Atlanta Atlanta, Georgia | |
| Gastro Florida Clearwater, Florida | |
| Gastroenterology Associates Greenville, South Carolina | |
| Hospital Clinic i Provincial de Barcelona Barcelona, | Isabel Graupera - (igraupe@clinic.cat) |
| Hospital La Fe Valencia, | Almundena Cubells Garcia - (almudena_cubells@iislafe.es) Laura Consuelo Arnal - (contratos_ec@iislafe.es) |
| Hospital Marques de Valdecilla Santander, Cantabria | Lorena C Estrada - (cayongonzalez@gmail.com) |
| Hospital Virgen del Rocio Seville, | Jose Manuel Caro Vega - (semanekro@gmail.com) Sara Mascort Arques - (sara.mascort@juntadeandalucia.es) |
| Houma Digestive Health Specialists Houma, Louisiana | |
| Indiana University - Division of Gastroenterology and Hepatology Indianapolis, Indiana | |
| Indianapolis Gastroenterology Research Foundation Indianapolis, Indiana | |
| Louisiana Research Center, LLC Shreveport, Louisiana | |
| Mayo Clinic Rochester, Minnesota | |
| Medical University of South Carolina Charleston, South Carolina | |
| Medstar Georgetown Transplant Institute Washington D.C., District of Columbia | |
| Mercy Medical Center Springfield, Massachusetts | |
| NorthShore University Healthsystem Evanston, Illinois | |
| Northwell Health - North Shore University Hospital Manhasset, New York | |
| Northwestern Medicine, Digestive Health Center Chicago, Illinois | |
| Pinnacle Clinical Research Live Oak, Texas | |
| Research Specialists of Texas Houston, Texas | |
| Rush University Medical Center Chicago, Illinois | |
| Rutgers - Robert Wood Johnson Medical School New Brunswick, New Jersey | |
| Saint Louis University - Gastroenterology and Hepatology, Clinical Research Unit St Louis, Missouri | |
| Schiff Center for Liver Disease/University of Miami Miami, Florida | |
| Silicon Valley Research Institute San Jose, California | |
| St. Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Stanford University Palo Alto, California | |
| Tampa General Medical Group Tampa, Florida | |
| The Children's Hospital at Montefiore, Division of Pediatric GI The Bronx, New York | |
| The Children's Hospital at Oklahoma University Medical Center Oklahoma City, Oklahoma | |
| The Ohio State University Wexner Medical Center Columbus, Ohio | |
| Tulane University School of Medicine New Orleans, Louisiana | |
| UF Health Gastroenterology Jacksonville, Florida | |
| University of California, Davis Sacramento, California | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Colorado Anschutz Medical Campus Aurora, Colorado | |
| University of Florida Gainesville, Florida | |
| University of Florida Hepatology Research at CTRB Gainesville, Florida | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| University of Louisville Louisville, Kentucky | |
| University of Miami Miami, Florida | |
| University of Michigan Ann Arbor, Michigan | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Vermont Medical Center Burlington, Vermont | |
| University of Virginia Charlottesville, Virginia | |
| University of Washington Seattle, Washington | |
| University of Wisconsin Hospital & Clinics Madison, Wisconsin | |
| Universitätsklinikum Aachen Aachen, | Angela Breuer - (angbreuer@ukaachen.de) |
| Universitätsklinikum Frankfurt Frankfurt, | Stefan Zeuzem, MD - (Stefan.Zeuzem@kgu.de) |
| Virginia Commonwealth University Richmond, Virginia | Alanda Perry Jones - (perryar@vcu.edu) |
| Weill Cornell Medical College New York, New York | |
| West Virginia University Morgantown, West Virginia |
Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+ (TEENS+)
Delorme, Janet - janet.delorme@vcuhealth.org
Bean, Melanie, K.
14519
HM20014304
Any Site, Any Site
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Delorme, Janet - (janet.delorme@vcuhealth.org) |
Study of INTERCEPT in Regions at Potential Risk for Zika Virus Tranfusion-Transmitted Infections (RedeS)
Fremeau, Jacqueline - jacqueline.barnhardt@vcuhealth.org
Green, Jeffrey, A
NCT03037164
HM20013456
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Stage A:
• Age ? 4 years.
• Patients who require or are expected to require a transfusion of RBC component(s), including red cell exchange transfusion
• Signed and dated informed consent form.
• Female patients of child-bearing potential must:
• Have negative serum or urine pregnancy tests prior to study treatment to rule out pregnancy, and
• Agree to use to use at least one method of birth control that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner for the duration of study participation and an additional 28 days. For 28-day +6-month extension study in chronically transfused patients: ? A diagnosis of a bone marrow failure syndrome requiring repeated RBC transfusion for congenital or acquired chronic anemia (e.g., sickle cell anemia, thalassemia, other hemoglobinopathies, myelodysplastic syndrome, aplastic anemia, chemotherapy or stem cell transplant etc.) For 28-day +6-month extension study in SCD patients requiring regular repeated RCE.
• Diagnosis of SCD, either HbSS, HbSC or HbSB0 thalassemia, confirmed by Hb electrophoresis, deoxyribonucleic acid (DNA) analysis or high-performance liquid chromatography (HPLC)
• Currently participating in an automated RCE transfusion program (for at least 3 months prior to enrollment) with 3-to-8 week intervals between RCE transfusion episodes Stage A: Exclusion Criteria
• Confirmed positive baseline serum/plasma antibody specific to IBS RBC (S 303 treated RBC) as determined by INTERCEPT S 303 antibody screening panel prior to receiving the first study transfusion
• Pregnant or breast feeding.
• Presence of an RBC warm autoantibody with evidence of active hemolysis.
• Positive DAT as defined below:
• A polyspecific-DAT reaction strength > 2+, or
• A polyspecific-DAT (any strength) in conjunction with pan-reactivity with a commercial IAT antibody screening panel that precludes the identification of underlying alloantibodies or indicates the presence of autoantibody.
• Have had an RBC transfusion within 7 days prior to randomization.
• Have received investigational products, including investigational blood products, pharmacologic agents or imaging materials, within 28 days prior to randomization. Prior receipt of conventional blood products tested with an investigational NAT test is not considered ground for exclusion.
• Patients presenting with or expected to have massive hemorrhage (?10 RBC units within 24 hours) or expected to require massive transfusion protocols. Planned red cell exchange does not apply.
• Patients who require neonatal transfusions and intrauterine transfusions.
• Pre-existing antibody to RBC antigens that may make the provision of compatible study RBC components difficult.
• History of transfusion reactions requiring washed RBCs, volume reduced RBC, or RBCs with additive solution removed.
• Patients with documented IgA deficiency or a history of severe allergic reactions to blood products.
• For SCD patients to be enrolled into the repeated RCE 28-day +6-month arm of the study:
• A history of acute chest syndrome in the last 6 months, or hyperhemolysis syndrome at any time.
• Clinical evidence of splenic hyperfunction or splenic enlargement: ?18 cm in longitudinal diameter (diagnosed at the Investigator's discretion according to the data available, with ultrasound data being preferable).
• Currently receiving chemotherapy for treatment of cancer. Hydroxyurea for SCD is acceptable if subject has been on stable therapy for 3 months and no changes to dosage are planned.
• Subject is in active treatment with renal dialysis.
• Any subject for whom a substantial change in the number of RBC components transfused is anticipated due to anticipated splenectomy, bone marrow transplant, surgery or other change in clinical status.
• Subject with known G6PD deficiency or requiring treatment with medications that are known to adversely affect RBC viability or bone marrow function.
Inclusion Criteria:
• Age ? 4 years.
• Patients who require or are expected to require a transfusion of RBC component(s), including red cell exchange transfusion
• Signed and dated informed consent form.
• Female patients of child-bearing potential must:
• Have negative serum or urine pregnancy tests prior to study treatment to rule out pregnancy, and
• Agree to use to use at least one method of birth control that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner for the duration of study participation and an additional 28 days. For 28-day +6-month extension study in chronically transfused patients: ? A diagnosis of a bone marrow failure syndrome requiring repeated RBC transfusion for congenital or acquired chronic anemia (e.g., sickle cell anemia, thalassemia, other hemoglobinopathies, myelodysplastic syndrome, aplastic anemia, chemotherapy or stem cell transplant etc.) For 28-day +6-month extension study in SCD patients requiring regular repeated RCE.
• Diagnosis of SCD, either HbSS, HbSC or HbSB0 thalassemia, confirmed by Hb electrophoresis, deoxyribonucleic acid (DNA) analysis or high-performance liquid chromatography (HPLC)
• Currently participating in an automated RCE transfusion program (for at least 3 months prior to enrollment) with 3-to-8 week intervals between RCE transfusion episodes Stage A: Exclusion Criteria
• Confirmed positive baseline serum/plasma antibody specific to IBS RBC (S 303 treated RBC) as determined by INTERCEPT S 303 antibody screening panel prior to receiving the first study transfusion
• Pregnant or breast feeding.
• Presence of an RBC warm autoantibody with evidence of active hemolysis.
• Positive DAT as defined below:
• A polyspecific-DAT reaction strength > 2+, or
• A polyspecific-DAT (any strength) in conjunction with pan-reactivity with a commercial IAT antibody screening panel that precludes the identification of underlying alloantibodies or indicates the presence of autoantibody.
• Have had an RBC transfusion within 7 days prior to randomization.
• Have received investigational products, including investigational blood products, pharmacologic agents or imaging materials, within 28 days prior to randomization. Prior receipt of conventional blood products tested with an investigational NAT test is not considered ground for exclusion.
• Patients presenting with or expected to have massive hemorrhage (?10 RBC units within 24 hours) or expected to require massive transfusion protocols. Planned red cell exchange does not apply.
• Patients who require neonatal transfusions and intrauterine transfusions.
• Pre-existing antibody to RBC antigens that may make the provision of compatible study RBC components difficult.
• History of transfusion reactions requiring washed RBCs, volume reduced RBC, or RBCs with additive solution removed.
• Patients with documented IgA deficiency or a history of severe allergic reactions to blood products.
• For SCD patients to be enrolled into the repeated RCE 28-day +6-month arm of the study:
• A history of acute chest syndrome in the last 6 months, or hyperhemolysis syndrome at any time.
• Clinical evidence of splenic hyperfunction or splenic enlargement: ?18 cm in longitudinal diameter (diagnosed at the Investigator's discretion according to the data available, with ultrasound data being preferable).
• Currently receiving chemotherapy for treatment of cancer. Hydroxyurea for SCD is acceptable if subject has been on stable therapy for 3 months and no changes to dosage are planned.
• Subject is in active treatment with renal dialysis.
• Any subject for whom a substantial change in the number of RBC components transfused is anticipated due to anticipated splenectomy, bone marrow transplant, surgery or other change in clinical status.
• Subject with known G6PD deficiency or requiring treatment with medications that are known to adversely affect RBC viability or bone marrow function.
Device: INTERCEPT Blood System for Red Blood Cells, Device: Conventional (Control)
Anemia
INTERCEPT, Red Blood Cells, RBC, Pathogen Inactivation, Zika, Cerus, Pathogen Reduction
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Study Locations
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| Location | Contacts |
|---|---|
| Baylor St. Luke's Medical Center Houston, Texas | Arthur Bracey, MD - (arthur.bracey@commonspirit.org) |
| Grady Health System Atlanta, Georgia | Ross Fasano, MD - (scdresearch@emory.edu) Hailly Butler, BSN |
| HIMA San Pablo Hospital Caguas, | |
| Mayo Clinic Jacksonville Jacksonville, Florida | |
| Menonita General Hospital Aibonito, | |
| San Juan Bautista School of Medicine Clinical Research Unit Caguas, | |
| UT Southwestern Medical Center Dallas, Texas | Ravi Sarode, MD - (Ravi.Sarode@UTSouthwestern.edu) |
| Virginia Commonwealth University Richmond, Virginia | Jeffrey A Green, Dr - (jeffrey.green@vcuhealth.org) |
| Yale University New Haven, Connecticut |
Use of Simultaneous Multi-Slice Imaging for Pediatric Brain MRI Compared with Standard TSE Sequences
Lessard, Margaret - margaret.lessard@vcuhealth.org
Vorona, Gregory
14702
HM20014210
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Lessard, Margaret - (margaret.lessard@vcuhealth.org) |
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
BMS Study Connect Contact Center www.BMSStudyConnect.com - Clinical.Trials@bms.com
McCarty, John, M.
NCT03435796
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Inclusion Criteria:
• Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
• Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
Exclusion Criteria:
Not Applicable
Other protocol-defined inclusion/exclusion criteria apply
Genetic: Gene-modified (GM) T cell therapy
Neoplasms
Long-term follow up, Gene-Modified T Cells, CAR T Cell
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Show 217 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien Wien, | |
| Arizona Cancer Center Scottsdale, Arizona | |
| Avera Cancer Institute Sioux Falls, South Dakota | |
| Azienda Ospedaliera Citta della Salute e della Scienza di Torino Torino, Piedmont | |
| Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi Bologna, | |
| Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette Turin, | |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Baptist Cancer Center Memphis, Tennessee | |
| Baylor Scott and White Health Temple, Texas | |
| CHRU de Lille France Lille Cedex, | |
| CHU Hotel Dieu Nantes Cedex 01, | |
| CHU La Miletrie Poitiers Cedex, | |
| CHU Montpellier - Hôpital Saint Eloi Montpellier CEDEX 5, | |
| CIUSSS de l'Est-de-l'Ile-de-Montreal Montreal, Quebec | |
| Cancer Center Of Kansas Wichita, Kansas | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Lyon-Sud Pierre-Bénite, Auvergne-Rhône-Alpes | |
| Charite -Universitätsmedizin Berlin Berlin, | |
| Christie Hospital NHS Trust Manchester, | |
| City of Hope Duarte, California | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Cleveland Clinic Foundation Cleveland, Ohio | Brian Hill, Site 01062 |
| Clinica Universidad de Navarra Madrid, | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Columbia University Medical Center/New York-Presbyterian Hospital New York, New York | |
| Dana-Farber/Mass General Brigham Cancer Care, Inc Boston, Massachusetts | |
| Duke University Medical Center Durham, North Carolina | |
| Erasmus Medical Center - Daniel den Hoed Rotterdam, | |
| Florida Hospital Transplant Institute Orlando, Florida | |
| Fondazione IRCCS Istituto Nazionale dei Tumori Milan, | |
| Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) Monza, | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT) Indianapolis, Indiana | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | Jordan Gauthier, Site 01110 |
| Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin | |
| Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin | Meera Mohan, Site 01178 |
| Gustave Roussy Villejuif, Val-de-Marne | |
| H. Lee Moffitt Cancer Center and Research Institute University of South Florida Tampa, Florida | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Helsinki University Central Hospital (HUCH) Helsinki, | |
| Hematology Oncology and clinical immunology / Heinrich-Heine-University Dusseldorf, | |
| Hematology and Oncology Associates of SC, LLC Greenville, South Carolina | |
| Hematology and Oncology Associates of SC, LLC Greenville, South Carolina | Saeeda Chowdhury, Site 01034 |
| Hokkaido University Hospital Sapporo, Hokkaido | |
| Hopital Robert Debre Reims, | |
| Hopital Saint Louis Paris, | |
| Hopitaux de La Timone Marseille, Bouches-du-Rhône | |
| Hospital 12 de Octubre Madrid, | |
| Hospital Infantil Universitario Nino Jesus Madrid, | |
| Hospital Saint Louis Paris, | |
| Hospital San Joan de Deu Barcelona Esplugues de Llobregat, | |
| Hospital Universitari Germans Trias i Pujol ICO Badalona Barcelona, | |
| Hospital Universitario Vall D Hebron Barcelona, | |
| Hospital Virgen del Rocio Seville, | |
| IN Univ Simon Cancer Center Indianapolis, Indiana | |
| IN Univ Simon Cancer Center Indianapolis, Indiana | Rafat Abonour, Site 01161 |
| Icahn School of Medicine at Mount Sinai New York, New York | |
| Illinois Cancer Specialists The Woodlands, Texas | |
| Inselspital Bern Bern, | |
| Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona Barcelona, | |
| Institut Paoli-Calmettes Marseille, Bouches-du-Rhône | |
| Institut Universitaire du Cancer de Toulouse - Oncopole Toulouse, Haute-Garonne | |
| Institute for Pediatric Hematology - Oncology, Leon Berard Cancer Center Lyon, | |
| Intermountain Healthcare - LDS Hospital Salt Lake City, Utah | |
| Istituto Clinico Humanitas Rozzano, | |
| Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Napoli, | |
| Japan Red Cross Medical Center Shibuya-ku, | |
| Jichi Medical University Hospital Tochigi, | |
| Juravinski Cancer Centre Hamilton, Ontario | |
| Kansas University Medical Center Kansas City, Kansas | |
| Karmanos Cancer Center Wayne State University Detroit, Michigan | |
| Karmanos Cancer Center Wayne State University Detroit, Michigan | Abhinav Deol, Site 01025 |
| Karolinska University Hospital Huddinge Stockholm, | |
| Kings College Hospital London, | |
| Kinikum der Universitaeat zu Koeln Koeln, | |
| Kyushu University Hospital Fukuoka, | |
| LMU Klinikum der Universitat München, | |
| Levine Cancer Institute Charlotte, North Carolina | |
| Local Institution - 02301 Toronto, Ontario | Site 02301 |
| Local Institution - 03151 Koeln, | Site 03151 |
| Local Institution - 03153 Ulm, | Site 03153 |
| Local Institution - 03154 München, | Site 03154 |
| Local Institution - 03501 Würzburg, | Site 03501 |
| Local Institution - 04301 Rotterdam, | Site 04301 |
| Local Institution - 05351 Gent, | Site 05351 |
| Local Institution - 07602 Ancona, | Site 07602 |
| Local Institution - 08253 Sevilla, | Site 08253 |
| Local Institution - 08451 Barcelona, | Site 08451 |
| Local Institution - 08601 Madrid, | Site 08601 |
| Local Institution - 08701 Pamplona, | Site 08701 |
| Local Institution - 09201 Pierre-Benite CEDEX, | Site 09201 |
| Local Institution - 09203 Poitiers Cedex, | Site 09203 |
| Local Institution - 09206 Montpellier CEDEX 5, | Site 09206 |
| Local Institution - 09401 Nantes Cedex 01, | Site 09401 |
| Local Institution - 10502 Manchester Withington, | Site 10502 |
| Local Institution - 12101 Wien, | Site 12101 |
| Local Institution - 13203 Osaka, | Site 13203 |
| Local Institution - 13601 Chuo-ku, Tokyo | Site 13601 |
| Local Institution - 13602 Minato-ku, Tokyo | Site 13602 |
| Local Institution - 13802 Shimotsuke, | Site 13802 |
| Local Institution - 13805 Fukuoka, | Site 13805 |
| Local Institution - 13806 Sapporo-shi, Hokkaido | Site 13806 |
| Local Institution - 15001 Stockholm, | Site 15001 |
| Lombardi Cancer Center - Georgetown University Hospital Washington, District of Columbia | |
| Loyola University Medical Center Maywood, Illinois | |
| Massachusetts General Hospital / Dana-Farber Cancer Institute Boston, Massachusetts | |
| Massachusetts General Hospital / Dana-Farber Cancer Institute Boston, Massachusetts | Jeremy Abramson, Site 01012 |
| Massachusetts General Hospital / Dana-Farber Cancer Institute Boston, Massachusetts | Nikhil Munshi, Site 01107 |
| Mayo Clinic Rochester, Minnesota | |
| Mayo Clinic Rochester, Minnesota | Yi Lin, Site 01105 |
| Mayo Clinic Phoenix Phoenix, Arizona | |
| Medizinische Klinik II ZIM,Hamatologie Onkologie Uniklinik Frankfurt Frankfurt, | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Morristown Memorial Hosp Morristown, New Jersey | |
| NYU Langone Laura and Isaac Perlmutter Cancer Center New York, New York | |
| National Cancer Center Hospital Chuo-ku, Tokyo | |
| National Cancer Institute Bangkok, | |
| New York Oncology Hematology P.C. Albany, New York | |
| Northside Hospital, Inc Atlanta, Georgia | |
| Northwest Medical Specialties PLLC Tacoma, Washington | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Northwestern Memorial Hospital Chicago, Illinois | Reem Karmali, Site 01014 |
| Norton Cancer Institute Louisville Oncology Louisville, Kentucky | |
| Oncology Hematology Care, Inc. Cincinnati, Ohio | |
| Oregon Health and Science University OHSU Portland, Oregon | |
| Osaka City University Hospital Osaka, | |
| Oslo Universitetssykehus Oslo, | |
| Ospedale Pediatrico Bambino Gesu Roma, | |
| Ospedali Riuniti di Ancona Ancona, | |
| Princess Margaret Cancer Centre Toronto, Ontario | |
| Princess Maxima Center for Pediatric Oncology Utrecht, | |
| Providence Cancer Institute Southfield, Michigan | |
| Providence Portland Medical Center Portland, Oregon | |
| Providence Portland Medical Center Portland, Oregon | Stacy Lewis, Site 01028 |
| Regional Cancer Care Associates LLC East Brunswick, New Jersey | |
| Robert-Rössle-Klinik im HELIOS Klinikum Berlin-Buch Klinik für Hämatologie, Onkologie u. Tumorimmuno Berlin, | |
| Roswell Park Cancer Institute Buffalo, New York | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Sam Clinical Research Center San Antonio, Texas | |
| Sam Clinical Research Center San Antonio, Texas | Julio Cesar Alvarenga Thiebaud, Site 01211 |
| Sarah Cannon Research Inst Nashville, Tennessee | |
| Seattle Children's Hospital Seattle, Washington | |
| Sidney Kimmel Comp Cancer Center at Johns Hopkins Baltimore, Maryland | |
| Sidney Kimmel Comp Cancer Center at Johns Hopkins Baltimore, Maryland | Syed Abbas Ali, Site 01017 |
| Siteman Cancer Center Saint Louis, Missouri | |
| Somers Cancer Research Building Shirley Southampton, | |
| Stanford Cancer Center Palo Alto, California | |
| Sutter Hematology and Oncology Sacramento, California | |
| Swedish Cancer Institute Seattle, Washington | |
| Texas Oncology Dallas, Texas | |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas, Texas | |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas, Texas | Houston Holmes, Site 01180 |
| Texas Oncology, P.A. - Tyler Tyler, Texas | |
| Texas Oncology, P.A. - Tyler Tyler, Texas | Habte Yimer, Site 01054 |
| The Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| The Leeds Teaching Hospitals NHS Trust - St James's University Hospital Leeds, | |
| The Mayo Clinic - Jacksonville, Davis-E Jacksonville, Florida | |
| The Mayo Clinic - Jacksonville, Davis-E Jacksonville, Florida | Sikander Ailawadhi, Site 01201 |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| Tokai University Hospital Iseharashi, Kanagawa | |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyō City, | |
| Tokyo Women's Medical University Hospital Shinjuku-ku, Tokyo, | |
| Toranomon Hospital Minato-ku, Tokyo | |
| UCL Cancer Institute London, | |
| UCLA Medical Centre-Santa Monica Santa Monica, California | |
| UPMC Cancer Pavillion Pittsburgh, Pennsylvania | |
| UPMC Cancer Pavillion Pittsburgh, Pennsylvania | Alison Sehgal, Site 01210 |
| UT Southwestern Medical Center Dallas, Texas | |
| UZ Gent Ghent, | |
| Universita La Sapienza Roma, | |
| Universitaetsklinikum Hamburg-Eppendorf Hamburg, | |
| Universitaetsklinikum Muenster Münster, | |
| Universitaetsklinikum Tuebingen Tübingen, Baden-Wurttemberg | |
| Universitario de Salamanca - Hospital Clinico Salamanca, | |
| Universitatsklinikum Carl Gustav Carus an der TU Dresden Dresden, | |
| Universitatsklinikum Heidelberg Heidelberg, | |
| Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II Würzburg, | |
| University Hospital Leuven Leuven, | |
| University Hospital of Ulm Ulm, | |
| University Hospitals of Cleveland Cleveland, Ohio | |
| University of Alabama Birmingham Birmingham, Alabama | |
| University of Alabama Birmingham Birmingham, Alabama | Luciano Costa, Site 01171 |
| University of Calgary Calgary, Alberta | |
| University of California San Diego Moores Cancer Center La Jolla, California | |
| University of California, San Francisco- California San Francisco, California | |
| University of Chicago Medical Center Chicago, Illinois | |
| University of Colorado Cancer Center Aurora, Colorado | |
| University of Colorado Cancer Center Aurora, Colorado | Manali Kamdar, Site 01208 |
| University of Kentucky Lexington, Kentucky | |
| University of Maryland - Greenebaum Comprehensive Cancer Center Baltimore, Maryland | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | |
| University of Minnesota Minneapolis, Minnesota | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of Nebraska Medical Center Omaha, Nebraska | Matthew Lunning, Site 01015 |
| University of Oklahoma Peggy and Charles Stephenson Cancer Center Oklahoma City, Oklahoma | |
| University of Pennsylvania Perelman Center for Advanced Medicine Philadelphia, Pennsylvania | |
| University of Pennsylvania Perelman Center for Advanced Medicine Philadelphia, Pennsylvania | Stephen Schuster, Site 01016 |
| University of Rochester James P. Wilmot Cancer Center Rochester, New York | |
| University of Texas- MD Anderson Houston, Texas | |
| University of Texas- MD Anderson Houston, Texas | Hun Ju Lee, Site 01013 |
| University of Utah - Huntsman Cancer Institute Salt Lake City, Utah | |
| University of Utah - Huntsman Cancer Institute Salt Lake City, Utah | Douglas Sborov, Site 01199 |
| University of Virginia Health System Charlottesville, Virginia | |
| University of Virginia Health System Charlottesville, Virginia | Indumathy Varadarajan, Site 01065 |
| University of Wisconsin Madison, Wisconsin | |
| University of Wisconsin Madison, Wisconsin | Natalie Callander, Site 01036 |
| Vancouver General Hospital Vancouver, British Columbia | |
| Virginia Commonwealth University Richmond, Virginia | |
| Virginia Oncology Associates Newport News, Virginia | |
| Vrije Universiteit Medisch Centrum (VUMC) Amsterdam, | |
| Weill Cornell Medicine / New York Presbyterian Hospital New York, New York | |
| Willamette Valley Cancer Institute Eugene, Oregon | |
| Winship Cancer Institute of Emory University Atlanta, Georgia | |
| Winship Cancer Institute of Emory University Atlanta, Georgia | Sagar Lonial, Site 01103 |
| Yale Cancer Center New Haven, Connecticut | |
| Yale Cancer Center New Haven, Connecticut | Iris Isufi, Site 01059 |
Neuroblastoma Maintenance Therapy Trial (NMTT)
BCC Enroll - BCCEnroll@pennstatehealth.psu.edu
Gowda, Madhu, S
NCT02679144
HM20015342
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Inclusion Criteria:
* All patients must have a pathologically confirmed diagnosis of neuroblastoma, \< 30.99 years of age and classified as high risk at the time of diagnosis. Exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible.
* All patients must be in complete remission (CR):
• No evidence of residual disease on scan
• No evidence of disease metastatic to bone marrow. * Specific Criteria by Stratum: Stratum 1/1B: All patients must have completed standard upfront therapy that replicates treatment which patients who were enrolled on ANBL0032 received, including: intensive induction chemotherapy and (if feasible) resection of primary tumor, followed by: consolidation with high-dose chemotherapy with stem cell transplant and radiotherapy, followed by: immunotherapy with Ch14.18/IL-2/GM-CSF (dinutuximab) and retinoic acid;. All subjects on Stratum 1/B must have also met the following criteria: • A pre-transplant disease status evaluation that met International Neuroblastoma Response Criteria (INRC) for CR (complete response), VGPR (very good partial response), or PR (partial response) for primary site, soft tissue metastases and bone metastases. Patients who meet those criteria must also meet the protocol-specified criteria for bone marrow response prior to transplant as outlined below: No more than 10% tumor involvement (based on total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy. Stratum 2: Neuroblastoma that is in first complete remission following standard upfront therapy different from that described for Stratum 1. Stratum 3: Neuroblastoma that failed to have a response of at least PR following induction chemotherapy and surgical resection of the primary tumor, but that has achieved CR following additional therapy. Stratum 4: Patients who have achieved a second or subsequent CR following relapse(s). * Pre-enrollment tumor survey: Prior to enrollment on this study, a determination of mandatory disease staging must be performed: * Tumor imaging studies including * Bilateral bone marrow aspirates and biopsy * This disease assessment is required for eligibility and preferably should be done within 2 weeks prior to enrollment, but must be done within a maximum of 4 weeks before enrollment. * Timing from prior therapy: Stratum 1/1B: Enrollment no later than 60 days after completion of upfront therapy, (last dose of cis-retinoic acid) with a maximum of 6 cycles of cis-retinoic acid maintenance therapy. Stratum 2, 3 and 4: Enrollment no later than 60 days from last dose of the most recent therapy. * Patients must have a Lansky or Karnofsky Performance Scale score of \> 50% and patients must have a life expectancy of ≥ 2 months. * All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated below. * Patients must have adequate organ functions at the time of registration: * Hematological: Total absolute phagocyte count ≥1000/μL * Liver: Subjects must have adequate liver function * Renal: Adequate renal function * Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding. * Written informed consent in accordance with institutional and FDA (food and drug administration) guidelines must be obtained from all subjects (or patients' legal representative).
Exclusion Criteria:
* BSA (Body Surface Area) of \<0.25 m2.
* Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
* Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from hematological and bone marrow suppression effects of prior chemotherapy.
* Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
* Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded. DRUG: Difluoromethylornithine (DFMO)
Neuroblastoma
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Study Locations
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| Location | Contacts |
|---|---|
| Alberta Children's Hospital Calgary, Alberta | Sherry Qian - (Sherry.Qian@albertahealthservices.ca) |
| All Children's Hospital Johns Hopkins Medicine St. Petersburg, Florida | Emily Riffle - (eriffle2@jhmi.edu) |
| Arkansas Children's Hospital Little Rock, Arkansas | Susan Hall - (HallSF@archildrens.org) |
| Arnold Palmer Hospital for Children Orlando, Florida | Michelle Pellet - (Michelle.Pellett@orlandohealth.com) |
| Augusta University Health Augusta, Georgia | Kimberly Gray - (kigray@augusta.edu) |
| CHUQ Québec, Quebec | Valérie-Ève Julien - (Valerie-Eve.Julien@crchudequebec.ulaval.ca) |
| CIUSSS de l'Estrie-CHUS Sherbrooke, Quebec | Cassandra Leblanc Desrochers - (cassandra.leblanc-desrochers.ciussse-chus@ssss.gouv.qc.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Krista Mueller - (kmueller@cancercare.mb.ca) |
| Children's Hospital and Clinics of Minnesota Minneapolis, Minnesota | Nel Siemsen - (Nel.Siemsen@childrensmn.org) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Sabrina Wigginton - (Sabrina.Wigginton@chkd.org) |
| Children's Medical Center Dallas, Texas | Michelle Rivas - (michelle.rivas@childrens.com) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Nicole Harvey - (ndharvey@cmh.edu) |
| Cleveland Clinic Children's Cleveland, Ohio | Luba Platt - (PLATTL@ccf.org) |
| Connecticut Children's Hospital Hartford, Connecticut | Nicole McCracken - (NMccracken@connecticutchildrens.org) |
| Dell Children's Blood and Cancer Center Austin, Texas | Rhea Robinson, RN - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Duke University Durham, North Carolina | Diana Sedito - (diana.sedito@duke.edu) |
| Gina Martin St Louis, Missouri | Gina Martin, RN - (gina.martin@health.slu.edu) |
| Hackensack University Medical Center Hackensack, New Jersey | Sherri Mayans - (sherri.mayans@hmhn.org) |
| Hasbro Children's Hospital Providence, Rhode Island | Christopher Bouressa - (cbouressa@lifespan.org) |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | Mary Beth Readwin - (mary.readwin2@corewellhealth.org) |
| Janesway Children's Health and Rehabilitation Centre St. John's, Newfoundland and Labrador | Bev Mitchell - (Beverlyj.mitchell@easternhealth.ca) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | Andrea Siu, MPH - (andrea.siu@kapiolani.org) |
| Kentucky Children's Hospital Lexington, Kentucky | Tammy Taylor - (ttayl2@email.uky.edu) |
| Levine Children's Hospital Charlotte, North Carolina | Jotnyce Green - (jontyce.green@atriumhealth.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | Ashley Hain - (ahain@childrenswi.org) |
| Medical University of South Carolina Charleston, South Carolina | Shanta Salzar, MD - (salzers@musc.edu) |
| Monroe Carrell Jr. Children's Hospital at Vanderbilt Nashville, Tennessee | Aida Constantinescu - (aida.constantinescu@vumc.org) |
| Montreal Children's Hospital Montreal, Quebec | Dominique Lafreniere - (Dominique.Lafreniere@MUHC.MCGILL.CA) |
| Nationwide Children's Hospital Columbus, Ohio | |
| New York University New York, New York | Anna Yaffe - (Anna.Yaffe@nyumc.org) |
| Penn State Milton S. Hershey Medical Center and Children's Hospital Hershey, Pennsylvania | Suzanne Treadway - (streadway@hmc.psu.edu) |
| Primary Children's Hospital Salt Lake City, Utah | Group Contact - (Pc-cog@imail.org) |
| Rady Children's Hospital San Diego, California | Franchesca Ramirez - (framirez@rchsd.org) |
| Randall Children's Hospital Portland, Oregon | Aaron White - (AJWHITE@lhs.org) |
| Rebecca McFall Chicago, Illinois | Jennifer Ward, MD - (jennifer.ward@aah.org) |
| Rocky Mountain Pediatric Hematology Denver, Colorado | Marlie Mounts - (Marlie.Mounts@HealthONEcares.com) |
| St. Joseph's Children's Hospital Tampa, Florida | Jennifer Manns, RN - (jennifer.manns@baycare.org) |
| St. Lukes Boise, Idaho | Callie Wiskus - (wiskusca@slhs.org) |
| Texas Children's Cancer and Hematology Centers Houston, Texas | Cara-Lee Fontaine - (clfontai@texaschildrens.org) |
| Tufts Medical Center Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland- Oakland, California | Group Contact - (PedOncRschOAK@ucsf.edu) |
| UHC Sainte-Justine Montreal, Quebec | Guillaume Leblanc - (guillaume.leblanc.hsj@ssss.gouv.qc.ca) |
| University of Alabama, Children's of Alabama Birmingham, Alabama | Bridget Tate - (btate@peds.uab.edu) |
| University of Florida Gainesville, Florida | Ashley Bayne - (abayne@UFL.EDU) |
| University of Louisville Louisville, Kentucky | Jennifer Miller - (Jennifer.Miller4@nortonhealthcare.org) |
| University of Massachusetts Medical School Worcester Worcester, Massachusetts | |
| Virginia Commonwealth University Richmond, Virginia | Mary Madu - (memadu@vcu.edu) |
APOLLO Study
Baldecchi, Mary - mary.baldecchi@vcuhealth.org
Gupta, Gaurav
NCT03615235
HM20014432
Diseases of Genitourinary System (580-629)
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Brigle, Nathaniel, W - (nathaniel.brigle@vcuhealth.org) |
Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy
O'Hara, Kathryn, A - kathryn.ohara@vcuhealth.org
Harper, Amy
NCT03863119
HM20016492
drug: Vamorolone
Diseases of Nervous System and Sense Organs (320-389)
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Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | O'Hara, Kathryn, A - (kathryn.ohara@vcuhealth.org) |
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors (A5481092)
Pfizer CT.gov Call Center - ClinicalTrials.gov_Inquiries@pfizer.com
Austin, Frances
NCT03709680
HM20017464
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Inclusion:
• Histologically confirmed relapsed or refractory solid tumor as follows:
• For dose escalation and dose determination parts: Histologically confirmed relapsed or refractory solid tumor (including CNS tumors but not lymphomas). Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll.
• For dose expansion and tumor specific cohorts: Histologically confirmed relapsed or refractory solid tumor including but not limited to EWS, rhabdoid tumor, rhabdomyosarcoma, neuroblastoma, and medulloblastoma. Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll. EWS is not eligible for TOPO and CTX tumor-specific cohorts.
• For randomized Phase 2 part: Histologically confirmed Ewing sarcoma at diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS rearrangement. Histopathology confirmation of both EWSR1-ETS or FUS-ETS rearrangement partners is required OR availability of formalin fixed paraffin embedded (FFPE) tumor tissue sample for central testing. Patient must have relapsed or have refractory disease and at least evaluable disease in at least one site other than bone marrow that can be followed by imaging.
• Age ≥2 and <21 years at the time of study entry.
• Lansky performance status ≥50% for patients ≤16 years of age, or Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 for patients >16 years of age.
• Adequate bone marrow function.
• Absolute neutrophil count ≥1000/mm3;
• Platelet count ≥100,000/mm3 (transfusion independent, no platelet transfusion in past 7 days prior study entry);
• Hemoglobin ≥8.5 g/dL (transfusion allowed).
• Adequate renal function: Serum creatinine level based on age/gender must within protocol specified limits.
• Adequate liver function, including:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) or ≤5 × ULN for age, if attributable to disease involvement of the liver;
• Total bilirubin ≤1.5 × ULN for age, unless the patient has documented Gilbert's syndrome.
• Patients enrolled to Phase 1 portion of the study and tumor specific cohorts must have measurable disease as defined by RECIST version 1.1 or modified RANO criteria for CNS disease or INRC for neuroblastoma. Patients with EWS enrolled to Phase 2 portion of the study are eligible with evaluable disease (eg, bone only disease with no soft tissue component).
• Recovered to CTCAE Grade ≤1, or to baseline, from any non-hematological acute toxicities of prior surgery, chemotherapy, immunotherapy, radiotherapy, differentiation therapy or biologic therapy, with the exception of alopecia.
• Serum/urine pregnancy test (for all girls ≥8 years of age) negative at screening and at the baseline visit. Exclusion:
• Phase 1 and tumor specific cohorts: For palbociclib with IRN and TMZ combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing regimen that includes TMZ. Patients who have received the combination of IRN and TMZ and did not progress while on these medications are eligible. For patients enrolling in the palbociclib with TOPO and CTX combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with a TOPO-containing regimen that includes CTX. Patients who have received the combination of TOPO and CTX and did not progress while on these medications are eligible. Phase 2 portion: prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing or TMZ-containing regimen. Patients who have received IRN and/or TMZ and did not progress while on these medications are eligible.
• Prior intolerability to IRN and/or TMZ plus/minus palbociclib with IRN and TMZ combination and prior intolerability to TOPO and/or CTX for TOPO and CTX combination.
• Use of strong cytochrome P450 (CYP) 3A inhibitors or inducers. Patients who are receiving strong uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) inhibitors within 12 days of Cycle 1 Day 1 (C1D1) are not eligible for the palbociclib with IRN and TMZ combination. Patients who are receiving strong UGT1A1 inhibitors within 12 days of C1D1 are eligible for the palbociclib with TOPO and CTX combination (See Section 5.7.1 for list of products.)
• Systemic anti cancer therapy within 2 weeks prior to study entry and 6 weeks for nitrosoureas.
• Prior irradiation to >50% of the bone marrow (see Appendix 9).
• Participation in other studies involving investigational drug(s) within 2 weeks or 5 half lives, whichever is longer, prior to study entry.
• Major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries.
• For IRN and TMZ with/without palbociclib combinations: known or suspected hypersensitivity to palbociclib, IRN and/or TMZ. For combination of palbociclib with TOPO and CTX: known or suspected hypersensitivity to palbociclib, TOPO and/or CTX.
• Patients with known symptomatic brain tumors or brain metastases and require steroids, unless they have been on a stable or on a decreasing steroid dose for >14 days.
• Patients with previously diagnosed brain metastases are eligible if they have completed their prior treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry for these metastases for at least 14 days post radiation and 4 weeks post-surgery and are neurologically stable.
• Hereditary bone marrow failure disorder.
• QTc >470 msec.
• History of clinically significant or uncontrolled cardiac disease, including:
• History of or active congestive heart failure; if patient had congestive heart failure resolve and >1 year from resolution, patient will be considered eligible;
• Clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation or Torsades de Pointes);
• Diagnosed or suspected congenital or acquired prolonged QT syndrome;
• Need for medications known to prolong the QT interval;
• Uncorrected hypomagnesemia or hypokalemia because of potential effects on the QT interval;
• Left ventricular ejection fraction <50% or shortening fraction <28%.
• Recent or ongoing clinically significant gastrointestinal disorder that may interfere with absorption of orally administered drugs (eg, gastrectomy).
• Severe acute or chronic medical or laboratory test abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
• Histologically confirmed relapsed or refractory solid tumor as follows:
• For dose escalation and dose determination parts: Histologically confirmed relapsed or refractory solid tumor (including CNS tumors but not lymphomas). Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll.
• For dose expansion and tumor specific cohorts: Histologically confirmed relapsed or refractory solid tumor including but not limited to EWS, rhabdoid tumor, rhabdomyosarcoma, neuroblastoma, and medulloblastoma. Patients with Diffuse Intrinsic Pontine Glioma do not require histological only radiographic confirmed relapse to enroll. EWS is not eligible for TOPO and CTX tumor-specific cohorts.
• For randomized Phase 2 part: Histologically confirmed Ewing sarcoma at diagnosis or at relapse, with presence of EWSR1-ETS or FUS-ETS rearrangement. Histopathology confirmation of both EWSR1-ETS or FUS-ETS rearrangement partners is required OR availability of formalin fixed paraffin embedded (FFPE) tumor tissue sample for central testing. Patient must have relapsed or have refractory disease and at least evaluable disease in at least one site other than bone marrow that can be followed by imaging.
• Age ≥2 and <21 years at the time of study entry.
• Lansky performance status ≥50% for patients ≤16 years of age, or Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 for patients >16 years of age.
• Adequate bone marrow function.
• Absolute neutrophil count ≥1000/mm3;
• Platelet count ≥100,000/mm3 (transfusion independent, no platelet transfusion in past 7 days prior study entry);
• Hemoglobin ≥8.5 g/dL (transfusion allowed).
• Adequate renal function: Serum creatinine level based on age/gender must within protocol specified limits.
• Adequate liver function, including:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) or ≤5 × ULN for age, if attributable to disease involvement of the liver;
• Total bilirubin ≤1.5 × ULN for age, unless the patient has documented Gilbert's syndrome.
• Patients enrolled to Phase 1 portion of the study and tumor specific cohorts must have measurable disease as defined by RECIST version 1.1 or modified RANO criteria for CNS disease or INRC for neuroblastoma. Patients with EWS enrolled to Phase 2 portion of the study are eligible with evaluable disease (eg, bone only disease with no soft tissue component).
• Recovered to CTCAE Grade ≤1, or to baseline, from any non-hematological acute toxicities of prior surgery, chemotherapy, immunotherapy, radiotherapy, differentiation therapy or biologic therapy, with the exception of alopecia.
• Serum/urine pregnancy test (for all girls ≥8 years of age) negative at screening and at the baseline visit. Exclusion:
• Phase 1 and tumor specific cohorts: For palbociclib with IRN and TMZ combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing regimen that includes TMZ. Patients who have received the combination of IRN and TMZ and did not progress while on these medications are eligible. For patients enrolling in the palbociclib with TOPO and CTX combination, prior treatment with a CDK4/6 inhibitor or progression while on treatment with a TOPO-containing regimen that includes CTX. Patients who have received the combination of TOPO and CTX and did not progress while on these medications are eligible. Phase 2 portion: prior treatment with a CDK4/6 inhibitor or progression while on treatment with an IRN-containing or TMZ-containing regimen. Patients who have received IRN and/or TMZ and did not progress while on these medications are eligible.
• Prior intolerability to IRN and/or TMZ plus/minus palbociclib with IRN and TMZ combination and prior intolerability to TOPO and/or CTX for TOPO and CTX combination.
• Use of strong cytochrome P450 (CYP) 3A inhibitors or inducers. Patients who are receiving strong uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) inhibitors within 12 days of Cycle 1 Day 1 (C1D1) are not eligible for the palbociclib with IRN and TMZ combination. Patients who are receiving strong UGT1A1 inhibitors within 12 days of C1D1 are eligible for the palbociclib with TOPO and CTX combination (See Section 5.7.1 for list of products.)
• Systemic anti cancer therapy within 2 weeks prior to study entry and 6 weeks for nitrosoureas.
• Prior irradiation to >50% of the bone marrow (see Appendix 9).
• Participation in other studies involving investigational drug(s) within 2 weeks or 5 half lives, whichever is longer, prior to study entry.
• Major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries.
• For IRN and TMZ with/without palbociclib combinations: known or suspected hypersensitivity to palbociclib, IRN and/or TMZ. For combination of palbociclib with TOPO and CTX: known or suspected hypersensitivity to palbociclib, TOPO and/or CTX.
• Patients with known symptomatic brain tumors or brain metastases and require steroids, unless they have been on a stable or on a decreasing steroid dose for >14 days.
• Patients with previously diagnosed brain metastases are eligible if they have completed their prior treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry for these metastases for at least 14 days post radiation and 4 weeks post-surgery and are neurologically stable.
• Hereditary bone marrow failure disorder.
• QTc >470 msec.
• History of clinically significant or uncontrolled cardiac disease, including:
• History of or active congestive heart failure; if patient had congestive heart failure resolve and >1 year from resolution, patient will be considered eligible;
• Clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation or Torsades de Pointes);
• Diagnosed or suspected congenital or acquired prolonged QT syndrome;
• Need for medications known to prolong the QT interval;
• Uncorrected hypomagnesemia or hypokalemia because of potential effects on the QT interval;
• Left ventricular ejection fraction <50% or shortening fraction <28%.
• Recent or ongoing clinically significant gastrointestinal disorder that may interfere with absorption of orally administered drugs (eg, gastrectomy).
• Severe acute or chronic medical or laboratory test abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Drug: Palbociclib, Drug: Temozolomide, Drug: Irinotecan, Drug: Topotecan, Drug: Cyclophosphamide
Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma
Ewing Sarcoma, EWS, Solid Tumor, Recurrent Solid Tumors, Refractory Solid Tumors, Bone Cancer, Bone Tumor, Bone Sarcoma, Soft Tissue Cancer, Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Pediatric Cancer, Childhood Cancer, Ewing Sarcoma Treatment, Palbociclib, CDK4/6 Inhibitor, Irinotecan, Temozolomide, Topotecan, Cyclophosphamide
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Study Locations
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| Location | Contacts |
|---|---|
| Alberta Children's Hospital Calgary, Alberta | |
| All India Institute of Medical Sciences New Delhi, National Capital Territory of Delhi | |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | |
| Arnold Palmer Hospital for Children Orlando, Florida | |
| Artemis Hospital Gurgaon, Haryana | |
| Asan Medical Center Seoul, | |
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone Marseille, | |
| Astrid Lindgrens Barnsjukhus Stockholm, | |
| BIONT, a.s. Bratislava, | |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház Miskolc, Borsod-abaúj-zemplén | |
| Buerger Center for Advanced Pediatric Care Philadelphia, Pennsylvania | |
| CHU Sainte-Justine Montréal, Quebec | |
| Carolinas Medical Center/Levine Children's Hospital Charlotte, North Carolina | |
| Children's Blood and Cancer Center Austin, Texas | |
| Children's Healthcare of Atlanta at Egleston Atlanta, Georgia | |
| Children's Healthcare of Atlanta at Scottish Rite Atlanta, Georgia | |
| Children's Healthcare of Atlanta, Medical Office Building Atlanta, Georgia | |
| Children's Hospital Colorado Aurora, Colorado | |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital and Research Center at Oakland Oakland, California | |
| Children's Hospital of Orange County Orange, California | |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Children's Hospital of the King's Daughters Norfolk, Virginia | |
| Children's Medical Center Dallas Dallas, Texas | |
| Children's Medical Center Plano Plano, Texas | |
| Children's Mercy Hospital Kansas City, Missouri | |
| Children's National Medical Center Washington D.C., District of Columbia | |
| Children's Of Alabama Birmingham, Alabama | |
| Children's Wisconsin Milwaukee, Wisconsin | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| Cincinnati Children's Liberty Campus Liberty Township, Ohio | |
| Cohen Children's Medical Center Queens, New York | |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's H/O Infusion Center Grapevine, Texas | |
| Cook Children's Medical Center Fort Worth, Texas | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dell Children's Medical Center Austin, Texas | |
| Detska Fakultna nemocnica s poliklinikou Banska Bystrica Banska Bystrica, | |
| Ege Universitesi Hastanesi Izmir, | |
| Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica, Oddelenie radiologie Banska Bystrica, | |
| Fakultni nemocnice v Motole Prague, | |
| Fundação Pio XII - Hospital de Câncer de Barretos Barretos, São Paulo | |
| Gustave Roussy Villejuif, Val-de-Marne | |
| Hacettepe Universite Hastaneleri Ankara, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hospital Infantil Universitario Nino Jesus Madrid, | |
| Hospital Sant Joan de Deu Barcelona, | |
| Hospital Universitari Vall d'Hebron Barcelona, | |
| Hospital Universitari i Politécnic La Fe Valencia, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Indiana University Indianapolis, Indiana | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Bordeaux, Aquitaine | |
| Institut nuklearnej a molekularnej mediciny Banska Bystrica, | |
| Instytut Matki i Dziecka Warsaw, Mazowieckie | |
| Intermountain - Primary Children's Hospital Salt Lake City, Utah | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | |
| Johns Hopkins All Children's Outpatient Care Center Saint Petersburg, Florida | |
| Johns Hopkins University Baltimore, Maryland | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Lucile Packard Children's Hospital Stanford, California | |
| Mayo Clinic in Rochester, Minnesota Rochester, Minnesota | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| MemorialCare Health System - Long Beach Medical Center Long Beach, California | |
| Montefiore Medical Center The Bronx, New York | |
| Morgan Stanley Children's Hospital of New York-Presbyetrian Hospital New York, New York | |
| Narodny ustav detskych chorob Bratislava, | |
| Narodny ustav detskych chorob Bratislava, | |
| National Cancer Center Goyang-si, Kyǒnggi-do | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Norton Children's Hospital Louisville, Kentucky | |
| Novak Center for Children's Health Louisville, Kentucky | |
| Oregon Health & Science University Portland, Oregon | |
| Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, | |
| Penn State Children's Hospital and Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania | |
| Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania | |
| Phoenix Children's Hospital Phoenix, Arizona | |
| Primary Children's Hospital Outpatient Services Salt Lake City, Utah | |
| Rajiv Gandhi Cancer Institute And Research Centre New Delhi, National Capital Territory of Delhi | |
| Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| SUNY Upstate Medical University Syracuse, New York | |
| Sahlgrenska Universitetssjukhuset Östra Gothenburg, | |
| Samsung Medical Center Seoul, | |
| Seattle Children's Hospital Seattle, Washington | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| Stollery Children's Hospital Edmonton, Alberta | |
| Texas Children's Hospital Houston, Texas | |
| The Hospital for Sick Children Toronto, Ontario | |
| Torrence E. Hemby Jr. Pediatric Hematology & Oncology Center Charlotte, North Carolina | |
| UCSF Medical Center San Francisco, California | |
| UF Health Shands Hospital Gainesville, Florida | |
| UMHAT Tsaritsa Yoanna-ISUL EAD Sofia, | |
| UPMC Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of California San Francisco, San Francisco, California | |
| University of Florida College of Medicine Jacksonville, Florida | |
| University of Illinois College of Medicine at Peoria Peoria, Illinois | |
| University of Michigan Health System Ann Arbor, Michigan | |
| University of Minnesota Minneapolis, Minnesota | |
| University of Minnesota Masonic Children's Hospital Minneapolis, Minnesota | |
| University of Minnesota Medical Center, Fairview Minneapolis, Minnesota | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw, | |
| Washington University School of Medicine St Louis, Missouri |
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Griffin, Jordyn
NCT03959085
HM20018568
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Inclusion Criteria:
* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.
* APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.
* Patients must be \> 365 days and \< 25 years of age
* White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):
* Age 1-9.99 years: WBC \>= 50,000/uL
* Age 10-24.99 years: Any WBC
* Age 1-9.99 years: WBC \< 50,000/uL with:
* Testicular leukemia
* CNS leukemia (CNS3)
* Steroid pretreatment.
* White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):
* Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction.
* Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \[WHO\] 2016 criteria) with \>= 25% blasts on a bone marrow (BM) aspirate;
* OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;
* OR A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.
* Patient has newly diagnosed B-LLy Murphy stages III or IV.
* Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.
* Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.
* Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.
Exclusion Criteria:
* Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group).
* With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.
* Patients who have received \> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
* Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \> 1,000/uL circulating leukemia cells.
* Patients with acute undifferentiated leukemia (AUL) are not eligible.
* For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply:
* T-lymphoblastic lymphoma.
* Morphologically unclassifiable lymphoma.
* Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.
* Patients with known Charcot-Marie-Tooth disease.
* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.
* Patients requiring radiation at diagnosis.
* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
* Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males. PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Bone Scan, DRUG: Calaspargase Pegol, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, BIOLOGICAL: Inotuzumab Ozogamicin, DRUG: Leucovorin Calcium, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Pegaspargase, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy, RADIATION: Radiation Therapy, DRUG: Thioguanine, DRUG: Vincristine Sulfate
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
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Show 230 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | Site Public Contact - (rechclinique@crchudequebec.ulaval.ca) |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Jim Pattison Children's Hospital Saskatoon, Saskatchewan | Site Public Contact - (Jessica.Marien@saskhealthauthority.ca) |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Madigan Army Medical Center Tacoma, Washington | |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Monash Medical Center-Clayton Campus Clayton, Victoria | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYP/Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma | |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Naval Medical Center -San Diego San Diego, California | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Northwestern Medicine Central DuPage Hospital Winfield, Illinois | Site Public Contact - (Claudine.Gamster@CadenceHealth.org) |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Palms West Radiation Therapy Loxahatchee Groves, Florida | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Royal Children's Hospital Parkville, Victoria | Site Public Contact - (Jordan.Hansford@rch.org.au) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Saskatoon Cancer Centre Saskatoon, | |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Starship Children's Hospital Auckland, | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | |
| Sutter Medical Center Sacramento Sacramento, California | |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (cogbchoak@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | |
| University Pediatric Hospital San Juan, | |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vannie Cook Children's Clinic McAllen, Texas | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wesley Medical Center Wichita, Kansas | Site Public Contact - (WesleyResearch@wesleymc.com) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | |
| Women's and Children's Hospital-Adelaide North Adelaide, South Australia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
National COVID Cohort Collaborative (N3C): A National Resource for Shared Analytics
ctrrecruit@vcu.edu
Gal, Tamas
16821
HM20019575
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Show 1 location
Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia |
ENhancing Recovery in CHildren Undergoing Surgery for IBD (ENRICH-US) (ENRICH-US)
Han, Jinfeng - jinfeng.han@vcuhealth.org
Sulkowski, Jason, P
NCT04060303
HM20018603
Modality: No vcuhs billing
Diseases of Digestive System (520-579)
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See this study on ClinicalTrials.gov
Show 1 location
Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Han, Jinfeng - (jinfeng.han@vcuhealth.org) |
Distress in the Pediatric Oncology Setting: Intervention versus Natural Adaptation
Jewell, Andrea - Andrea.Jewell@vcuhealth.org
Rohan, Jennifer
NCT04409301
HM20019000
Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Breast, Brain and Nervous System, Bones and Joints, Anus, Any Site, Non-Hodgkin's Lymphoma, Other Digestive Organ, Other Female Genital, Other Endocrine System, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Urinary, Other Skin, Other Respiratory and Intrathoracic Organs, Other Male Genital, Other Hematopoietic
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Show 1 location
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Jewell, Andrea - (Andrea.Jewell@vcuhealth.org) |
MAP to provide alpelisib (BYL719) for patients with PROS
Lessard, Margaret "Meg" - margaret.lessard@vcuhealth.org
Lastrapes, Kelly, K
NCT04085653
HM20023385
Show full eligibility criteria
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Patients eligible for inclusion in this Treatment Plan have to meet all of the following
criteria:
• Adult or pediatric patients ? 2 years of age, with a diagnosis of PROS preferably with evidence of a mutation in the PIK3CA gene
• The treating physician has determined that the patient's condition is severe or life threatening, treatment is necessary and there are no other feasible alternatives for the patient.
• Confirmed adequate bone marrow function Written patient informed consent must be obtained prior to start of treatment Exclusion criteria Patients eligible for this Treatment Plan must not meet any of the following criteria:
• Patient has history of hypersensitivity to any drugs or metabolites of PI3K inhibitor or any of the excipients of alpelisib.
• Patient with uncontrolled diabetes mellitus type I or not controlled type II (based on FPG and HbA1c, see inclusion criterion 2)
• Patient who has other concurrent severe and/or uncontrolled medical conditions that would, in the Treating Physician's judgment, contraindicate administration of alpelisib (eg. active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)
• Patient has a known history of Severe Cutaneous Adverse Reactions (SCAR) like Steven Johnson's syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
• History of pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
• Subject with Child Pugh score B or C
• Subjects with unresolved osteonecrosis of the jaw
• Subject is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of the treatment:
• Strong inducers of CYP3A4
• Inhibitors of BCRP
• Patient has a known history of Human Immunodeficiency Virus (HIV) infection (testing not mandatory unless required by local regulations or requirements).
• Patient who is concurrently being treated with drugs known to be strong inhibitors or inducers of the isoenzyme CYP3A; switching to different medications prior to start of program treatment is allowed within the last 5 days prior to starting program treatment
• Patient is currently receiving or has received systemic corticosteroids ? 2 weeks prior to start of program treatment, or who have not fully recovered from side effects of such treatment. Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
• Male patient who does not apply highly effective contraception during the treatment with alpelisib and through the duration as defined below after the final dose of alpelisib. Sexually active males should use a condom during intercourse while taking drug and for at least 4 weeks after stopping alpelisib and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
• Subject is not able to understand and to comply with treatment instructions and requirements
• Subject is a nursing (lactating) or pregnant woman as confirmed by a positive serum (hCG) test prior to initiating study treatment
• Subject is a woman of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during study treatment and at least for 1 week after the last dose of any study treatment. Highly effective contraception methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject ). Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
• Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject
• Use of oral (estrogen and progesterone), injected or implanted combined hormonal method of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormonal vaginal ring or transdermal hormone contraception. In case of use or oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Note: Women are considered postmenopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
• Subject is a sexually active male unwilling to use a condom during intercourse while taking study treatment, and for 1 week after stopping alpelisib. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm during study and up to the time period specified above.
• Adult or pediatric patients ? 2 years of age, with a diagnosis of PROS preferably with evidence of a mutation in the PIK3CA gene
• The treating physician has determined that the patient's condition is severe or life threatening, treatment is necessary and there are no other feasible alternatives for the patient.
• Confirmed adequate bone marrow function Written patient informed consent must be obtained prior to start of treatment Exclusion criteria Patients eligible for this Treatment Plan must not meet any of the following criteria:
• Patient has history of hypersensitivity to any drugs or metabolites of PI3K inhibitor or any of the excipients of alpelisib.
• Patient with uncontrolled diabetes mellitus type I or not controlled type II (based on FPG and HbA1c, see inclusion criterion 2)
• Patient who has other concurrent severe and/or uncontrolled medical conditions that would, in the Treating Physician's judgment, contraindicate administration of alpelisib (eg. active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)
• Patient has a known history of Severe Cutaneous Adverse Reactions (SCAR) like Steven Johnson's syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
• History of pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
• Subject with Child Pugh score B or C
• Subjects with unresolved osteonecrosis of the jaw
• Subject is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of the treatment:
• Strong inducers of CYP3A4
• Inhibitors of BCRP
• Patient has a known history of Human Immunodeficiency Virus (HIV) infection (testing not mandatory unless required by local regulations or requirements).
• Patient who is concurrently being treated with drugs known to be strong inhibitors or inducers of the isoenzyme CYP3A; switching to different medications prior to start of program treatment is allowed within the last 5 days prior to starting program treatment
• Patient is currently receiving or has received systemic corticosteroids ? 2 weeks prior to start of program treatment, or who have not fully recovered from side effects of such treatment. Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
• Male patient who does not apply highly effective contraception during the treatment with alpelisib and through the duration as defined below after the final dose of alpelisib. Sexually active males should use a condom during intercourse while taking drug and for at least 4 weeks after stopping alpelisib and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
• Subject is not able to understand and to comply with treatment instructions and requirements
• Subject is a nursing (lactating) or pregnant woman as confirmed by a positive serum (hCG) test prior to initiating study treatment
• Subject is a woman of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during study treatment and at least for 1 week after the last dose of any study treatment. Highly effective contraception methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject ). Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
• Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject
• Use of oral (estrogen and progesterone), injected or implanted combined hormonal method of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormonal vaginal ring or transdermal hormone contraception. In case of use or oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Note: Women are considered postmenopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
• Subject is a sexually active male unwilling to use a condom during intercourse while taking study treatment, and for 1 week after stopping alpelisib. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm during study and up to the time period specified above.
Drug: alpelisib,
drug: Byl719, Modality: No vcuhs billing
PIK3CA-Related Overgrowth Spectrum (PROS), Congenital Anomalies (740-759)
adult, pediatric, BYL719, PIK3CA, Overgrowth Spectrum, PROS, alpelisib
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Show 119 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| AI Dupont Children Hospital Wilmington, Delaware | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arkansas Childrens Hospital Dept. Pediatric/Div Hem/Onc Little Rock, Arkansas | |
| Atlantic Medical Group Morristown, New Jersey | |
| Boston Childrens Hospital Pediatric Heamatology Oncology Boston, Massachusetts | |
| Children s Healthcare of Atlanta Aflac Blood Cancer Center Atlanta, Georgia | |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Los Angeles Childen's Center for Cancer Los Angeles, California | |
| Children's Hospital Medical Center Cincinnati, Ohio | |
| Children's Hospital and Clinics of Minnesota Childrens Hosp/Clinic Minneapolis, Minnesota | |
| Children's Hospital and Regional Medical Center Seattle, Washington | |
| Children's Hospital and Regional Medical Center Seattle, Washington | |
| Children's Hospital of Philadelphia Pediatric Oncology Clinic Philadelphia, Pennsylvania | |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Children's Hospital of Richmond at VCU Pediatric Hematology Oncology Richmond, Virginia | |
| Children's National Med Center StudyCoord:ACZ886G2301/01E1/05 Washington, District of Columbia | |
| Children's Specialists of San Diego Medical Group San Diego, California | |
| Childrens Hospital of Wisconsin Milwaukee, Wisconsin | |
| Childrens National Hospital Washington, District of Columbia | |
| Childrens National Hospital Ctr - Cancer & Blood Disorders Washington, District of Columbia | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| Cincinnati Children's Hospital Medical Center Cancer & Blood Disease Inst. Cincinnati, Ohio | |
| Cohen Children's Medical Center of New York Oncology New Hyde Park, New York | |
| Dell Childrens Medical Center of Central Texas Austin, Texas | |
| Doernbecher Children's Hospital Portland, Oregon | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Lebonheur Children's Medical Center Memphis, Tennessee | |
| Lucile Packard Children s Hospital Stanford University Palo Alto, California | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Midwest Children's Cancer Center Milwaukee, Wisconsin | |
| Mission Hospital Asheville, North Carolina | |
| Monroe Carell Jr Childrens Hospital at Vanderbilt Nashville, Tennessee | |
| NYU Langone Health New York, New York | |
| NYU Laura and Isaac Perlmutter Cancer Center New York, New York | |
| Nicklaus Childrens Hospital Miami, Florida | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Novartis Investigative Site Ho Chi Minh City, | |
| Oklahoma State University Health Sciences Center Pediatric Hem/Onc Oklahoma City, Oklahoma | |
| Rady Children s Hospital Dept of Oncology San Diego, California | |
| Rady Children s Hospital Sickle Cell Disease Center San Diego, California | |
| Rady Childrens Hospital San Diego, California | |
| Roswell Park Cancer Institute Pediatrics Buffalo, New York | |
| Seattle Childrens Hospital Seattle, Washington | |
| Stanford University Medical Center Div. of Pediatric Rheumatology Palo Alto, California | |
| Texas Cancer Center ( Medical City Dallas Hospital) Dallas, Texas | |
| Texas Childrens Hospital Houston, Texas | |
| Texas Childrens Hospital CFTY720D2311 Houston, Texas | |
| Texas Childrens Hospital Oncology Department Houston, Texas | |
| The Childrens Hospital of Philadelphia Philadelphia, Pennsylvania | |
| The Childrens Hospital of Philadelphia Children's Hosp Philadelphia Philadelphia, Pennsylvania | |
| The University of Vermont Medical Center Burlington, Vermont | |
| UCLA Medical Center Los Angeles, California | |
| UT Southwestern Medical Center Pediatric Hematology/Onc Dallas, Texas | |
| UVA Children s Hospital Charlottesville, Virginia | |
| University of California at Los Angeles Los Angeles, California | |
| University of Iowa Health Care Dept of Pediatrics & Pulmonary Iowa City, Iowa | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Texas Southwestern Medical Center Regulatory Dallas, Texas | |
| University of Texas Southwestern Medical Center UT Southwestern Dallas, Texas | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Virginia Commonwealth University Richmond, Virginia | Lessard, Margaret "Meg" - (margaret.lessard@vcuhealth.org) |
| Virginia Mason Medical Center Seattle, Washington | |
| Virginia Mason Medical Center Buck 2 Seattle, Washington |
Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation
Dorothy Sung - dsung@nybc.org
McCarty, John, M.
NCT01656603
HM14815
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Inclusion Criteria:
• Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
• Patients: Patients of any age and either gender
• Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
Exclusion Criteria:
• Patients who are receiving licensed cord blood products (only)
• Patients who are receiving unlicensed cord blood products from other banks (only)
• Patients who are transplanted at non-US transplant centers
• Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
Biological: unlicensed CBU
Infusion Reactions
cord blood, transplantation, stem cells, adverse event
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Show 71 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania Medical Center Philadelphia, Pennsylvania | |
| Akron Children's Hospital Akron, Ohio | |
| Alfred I. DuPont Hospital for Children Wilmington, Delaware | |
| All Children's Hospital, John Hopkins Medicine Saint Petersburg, Florida | |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | |
| Arthur G. James Cancer Hospital Columbus, Ohio | |
| Barnes-Jewish Hospital at University of Washington / Sireman Cancer Center Saint Louis, Missouri | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Cedars Sinai Medical Center Los Angeles, California | |
| Children's Healthcare of Atlanta Atlanta, Georgia | |
| Children's Hopsital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | |
| Children's Hospital of Michigan Detroit, Michigan | |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | |
| Children's Medical Center of Dallas Dallas, Texas | |
| Children's National Medical Center Washington D.C., District of Columbia | |
| Children's Of Alabama Birmingham, Alabama | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| City of Hope Duarte, California | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Cohen Children's Medical Center of NY New Hyde Park, New York | |
| Cook Children's Medical Center Fort Worth, Texas | |
| Dana Farber Cancer Instistute Boston, Massachusetts | |
| Doernbecher Children's Hospital / Oregon Health & Science University Portland, Oregon | |
| Florida Hospital, Florida Center for Cellular Therapy Orlando, Florida | MD |
| Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance Seattle, Washington | |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | |
| Henry Ford Health System Detroit, Michigan | |
| Indiana University Indianapolis, Indiana | |
| James Graham Brown Cancer Center Louisville, Kentucky | |
| Loyola University Medical Center Maywood, Illinois | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic Arizona Phoenix, Arizona | |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Medical University of South Carolina Charleston, South Carolina | |
| Memorial Sloan-Kettering Cancer Center New York, New York | |
| Methodist Hospital / Texas Transplant Institute San Antonio, Texas | |
| Midwestern Regional Medical Center Zion, Illinois | |
| Mount Sinai Hospital New York, New York | |
| National Institutes of Health Bethesda, Maryland | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Nemour's Children's Clinic and Hospital Jacksonville, Florida | |
| New York Presbyterian Hospital WCMC New York, New York | |
| Northside Hosptal Atlanta, Georgia | |
| Northwell Health - North Shore University Hospital Manhasset, New York | |
| Northwestern Memorial Hospital Chicago, Illinois | |
| Penn State Health / Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania | Robert Greiner, MD |
| Phoenix Children's Hospital Phoenix, Arizona | |
| Presbyterian / St. Luke's Medical Center Denver, Colorado | |
| Rady Children's Hospital San Diego, California | |
| Seidman Cancer Center Cleveland, Ohio | |
| Southwestern Regional Medical Center Tulsa, Oklahoma | |
| St Jude Children's Research Center Memphis, Tennessee | |
| St. Louis University Hospital Saint Louis, Missouri | |
| Stanford Health Care San Jose, California | |
| Stephenson Oklahoma Cancer Center Oklahoma City, Oklahoma | |
| Texas Children's Cancer Center Houston, Texas | |
| The Children's Hospital of Colorado Aurora, Colorado | |
| The Nebraska Medical Center Omaha, Nebraska | Sachit Patel, MD |
| UCLA Healthcare Los Angeles, California | |
| UCSD Moores Cancer Center La Jolla, California | |
| University of Arizona Medical Center Tucson, Arizona | |
| University of Colorado Hospital Aurora, Colorado | |
| University of Miami Health System Sylvester Comprehensive Cancer Center Miami, Florida | |
| University of Miami/Jackson Memorial Hospital Miami, Florida | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Rochester Medical Center Rochester, New York | |
| University of Virginia Charlottesville, Virginia | |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia | |
| West Virginia University Hospitals Inc Morgantown, West Virginia | Kelly Ross, MD |
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs (NEAR4KIDs)
Hayley Buffman, MPH - buffmanh@chop.edu
Bain, Jesse
NCT02493478
HM20000941
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Inclusion Criteria:
* Primary advanced airway events (on patients of all ages) in the PICU, CICU, NICU, DR and ED including: Tracheal Intubation, Laryngeal mask placement, Emergency tracheostomy and/or cricothyrotomy
* Failed extubation attempts or unplanned extubations that require re-intubation will be considered a new primary intubation.
Exclusion Criteria:
* Primary advanced airway events (tracheal intubations, laryngeal mask placement, emergency tracheostomy and/or cricothyrotomy) in the Operating Suites. Failed or Difficult Intubation, Sequela, Intubation, Difficult, Intubation Complication
Intubation, Advanced airway intervention, Intensive care unit
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Show 87 locations
Study Locations
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| Location | Contacts |
|---|---|
| Aichi Children's Health and Medical Center Aichi, | |
| Akron Children's Hospital Akron, Ohio | |
| Albany Medical College Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Simon Parsons, MD - (simon.Parsons@albertahealthservices.ca) |
| American Family Children's Hospital - University of Wisconsin Madison, Wisconsin | |
| Arkansas Children's Hospital Little Rock, Arkansas | Office of Research and Sponsored Programs - (rcsanders@uams.edu) |
| Aster Hospitals - India Bengaluru, Karnataka | |
| Bambino Gesu Roma, | |
| Baylor - Christus Children's - Main Hospital Irving, Texas | Baylor College of Medicine Office of Research - (irb@bcm.edu) |
| Baylor - Christus Children's - Stone Oak San Antonio, Texas | Baylor College of Medicine Office of Research - (irb@bcm.edu) |
| Baylor - Christus Children's - Westover Hills San Antonio, Texas | Baylor College of Medicine Office of Research - (irb@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | |
| Beacon Children's Hospital South Bend, Indiana | |
| Boston Children's Hospital Boston, Massachusetts | |
| British Columbia Children's Hospital Vancouver, British Columbia | Gordon Krahn, MD - (gkrahn@cw.bc.ca) |
| CHU Sainte-Justine Montréal, Quebec | Guillaume Emeriaud, MD - (guillaume.emeriaud@umontreal.ca) |
| CHU Sainte-Justine Montréal, Quebec | |
| Cardiff & Vale University Health Board Cardiff, Wales | |
| Children's Hospital - Penn State Hershey Hershey, Pennsylvania | Ashley Derbyshire, MD - (aderbyshire@hmc.psu.edu) |
| Children's Hospital and Medical Center Omaha, Nebraska | |
| Children's Hospital of Atlanta - Scottish Rite Atlanta, Georgia | |
| Children's Hospital of Central California Madera, California | |
| Children's Hospital of Georgia Augusta, Georgia | |
| Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Children's Hospitals and Clinics of Minnesota Minneapolis, Minnesota | |
| Children's of Alabama at Birmingham Birmingham, Alabama | University of Alabama at Birmingham Institutional Review Board - (irb@uab.edu) |
| Cincinnati Hospital Medical Center Cincinnati, Ohio | |
| Cleveland Clinic Childrens Hospital Cleveland, Ohio | |
| Cohen Children's Medical Center Queens, New York | |
| Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire | Sholeen Nett, MD - (sholeen.t.nett@hitchcock.org) |
| Dell Children's Medical Center - Ascension Austin, Texas | |
| Duke Children's Hospital Durham, North Carolina | Kyle Rehder, MD - (kyle.rehder@duke.edu) |
| Emory University Atlanta, Georgia | Pradip Kamat, MD - (pradip.kamat@choa.org) |
| Foothills Medical Centre Calgary, | |
| Gillette Children's Specialty Health Saint Paul, Minnesota | |
| Hasbro Children's Hospital Providence, Rhode Island | Lee Polikoff, MD - (lee.polikoff@lifespan.org) |
| Hiroshima University Hiroshima, | |
| Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | |
| Hyogo Prefectural Kobe Children's Hospital Kobe, Hyōgo | |
| Jichi Medical University Hospital Tochigi, | |
| Johns Hopkins Medicine Baltimore, Maryland | Office of Human Subjects Research IRB - (jhmeirb@jhmi.edu) |
| KK Women's & Children's Hospital, Singapore Singapore, | Jan H Lee, MD - (lee.jan.hau@kkh.com.sg) |
| KK Women's and Children's Hospital Singapore, | |
| Kentucky Children's Hospital Lexington, Kentucky | Ashwin Krishna, MD - (ashwin.krishna@uky.edu) |
| Le Bonheur Children's Hospital Memphis, Tennessee | |
| Maria Fareri Children's Hospital (West Chester Medical) Valhalla, New York | Simon Li, MD - (lis@WCMC.com) |
| Medical City Children's Hospital Dallas, Texas | Kris Bysani, MD - (KrisBysani@gmail.com) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of Vienna (Medizinische Universität Wien) Vienna, | |
| Miami Children's Hospital Miami, Florida | |
| Morristown Medical Center Morristown, New Jersey | Atlantic Health System - (anita.richards@atlantichealth.org) |
| National Center for Child Health and Development Setagaya-Ku, Tokyo | |
| Nationwide Children's Hospital Columbus, Ohio | Anthony Lee, MD - (Anthony.Lee@nationwidechildrens.org) |
| Nemours Children's Health, Delaware Wilmington, Delaware | |
| New York Presbyterian Hospital Weill Cornell Medical College New York, New York | |
| Northwestern Medicine Prentice Women's Hospital Chicago, Illinois | |
| Norton Children's Hospital - University of Louisville Louisville, Kentucky | |
| Oishei Children's Hospital Buffalo, New York | Ryan Breuer, MD - (ryankbreuer@gmail.com) |
| Oregon Health and Science University Portland, Oregon | Paula Vanderford, MD - (vanderfo@ohsu.edu) |
| Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania | Kathleen May - (khay@hmc.psu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | PCH IRB - (swalker@phoenixchildrens.com) |
| Rainbow Children's Hospital Bangalore, | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Royal Brisbane and Women's Hospital Brisbane, Queensland | |
| Saitama Children's Medical Center Chuo-ku, Saitama | |
| Seattle Children's Hospital Seattle, Washington | Alisyn Franetich - (alisyn.franetich@seattlechildrens.org) |
| Starship Children's Hospital Auckland, | |
| Stony Brook Children's Hospital Stony Brook, New York | |
| The Children's Hospital at Montefiore Bronx, New York | |
| The Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Children's Hospital of Philadelphia IRB Office - (irboffice@chop.edu) |
| The Royal Children's Hospital Melbourne Parkville, | |
| The University of Manitoba Winnipeg, | |
| The University of Vermont Children's Hospital Burlington, Vermont | Iris Toedt-Pingel, MD - (iris.toedt-pingel@uvmhealth.org) |
| Tokyo Metropolitan Tokyo, | Takanari Ikeyama, MD - (taqnary@gmail.com) |
| UVA Children's Hospital Charlottesville, Virginia | Michelle Adu-Darko, MD - (maa7j@hscmail.mcc.virginia.edu) |
| University Hospital Schleswig-Holstein, Campus Luebeck, Children's Hospital Luebeck, | |
| University of Colorado Hospital Aurora, Colorado | John Heldens - (john.heldens@ucdenver.edu) |
| University of Maryland Baltimore, Maryland | |
| University of Rochester at Golisano Children's Hospital Rochester, New York | |
| University of Washington Medical Center Seattle, Washington | Alisyn Franetich - (alisyn.franetich@seattlechildrens.org) |
| University of Wisconsin - American Family Children's Hospital Shorewood Hills, Wisconsin | The University of Wisconsin IRB - (pjpeebles@wisc.edu) |
| University of Wisconsin - UnityPoint Meriter Madison, Wisconsin | Liz Michaels - (liz.michaels@unitypoint.org) |
| WakeMed Raleigh, North Carolina | Elizabeth Woodard, RN, PhD - (WakeMed_IRB_Office@wakemed.org) |
| WakeMed Health & Hospitals Raleigh, North Carolina | |
| Yale New Haven Children's Hospital New Haven, Connecticut | Stephen Latham, JD, PhD - (human.subjects@yale.edu) |
| Yale-New Haven Children's Hospital New Haven, Connecticut | John Giuliano, MD - (john.giuliano@yale.edu) |
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Gowda, Madhu, S
NCT03126916
HM20015351
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Inclusion Criteria:
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916)
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patient must be \>= 365 days and =\< 30 years of age at diagnosis
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible:
* Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:
* MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
* Age \> 547 days regardless of biologic features
* Patients with INRG stage MS disease with MYCN amplification
* Patients with INRG stage L2 disease with MYCN amplification
* Patients \> 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within 4 weeks of progression to stage M
* Patients \>= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within 4 weeks of progression to stage M
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing); patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high risk disease but subsequently found to meet the criteria will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/sex as follows:
* 1 to \< 2 years: male = 0.6; female = 0.6
* 2 to \< 6 years: male = 0.8; female = 0.8
* 6 to \< 10 years: male = 1; female = 1
* 10 to \< 13 years: male = 1.2; female = 1.2
* 13 to \< 16 years: male = 1.5; female = 1.4
* \>= 16 years: male = 1.7; female = 1.4
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \> 50% by echocardiogram or radionuclide angiogram
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): See ANBL2131 (NCT06172296) protocol for eligible high-risk neuroblastoma diagnoses
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In addition, all patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) Arm E must have tumors with an ALK aberration
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Given the lack of data with lorlatinib in infant populations, patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) must be \> 1 year of age at time of transfer to ANBL1531 (NCT03126916). Patients \< 1 year of age found to have a qualifying ALK alteration as part of ANBL2131 (NCT06172296) may continue to participate in ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients initially recognized to have high-risk disease must have received no more than one cycle of topotecan/cyclophosphamide either after enrollment to ANBL2131 (NCT06172296) or started emergently prior to enrollment to ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received up to one cycle of intermediate risk chemotherapy prior to initial enrollment to ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In order to facilitate patient transfer and ensure timely distribution of lorlatinib, there are no blood count requirements to meet at time of transfer from ANBL2131 (NCT06172296) to ANBL1531 ((NCT03126916) Arm E. Note the blood count criteria that must be met prior to start of Induction cycle 2 on Arm E. Lorlatinib therapy should start no sooner than day 1 of Induction cycle 2
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known irreversible grade 2 or greater atrioventricular (AV) block
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Due the potential psychiatric risks from lorlatinib, patients should not have a personal history of a serious psychiatric disorder requiring pharmacologic intervention or severe enough to be considered life-threatening
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution deems feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
Exclusion Criteria:
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with bone marrow failure syndromes
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Lactating females who plan to breastfeed their infants
* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have previously received treatment with lorlatinib or other ALK inhibitor
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have undergone treatment arm randomization callback or started induction cycle 2 on ANBL2131 (NCT06172296)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients with bone marrow failure syndromes
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Lactating females who plan to breastfeed their infants
* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration and Biopsy, DRUG: Busulfan, DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Dexrazoxane Hydrochloride, BIOLOGICAL: Dinutuximab, DRUG: Doxorubicin Hydrochloride, PROCEDURE: Echocardiography Test, DRUG: Etoposide Phosphate, RADIATION: External Beam Radiation Therapy, RADIATION: Iobenguane I-123, RADIATION: Iobenguane I-131, DRUG: Isotretinoin, DRUG: Lorlatinib, PROCEDURE: Magnetic Resonance Imaging, DRUG: Melphalan Hydrochloride, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Positron Emission Tomography, BIOLOGICAL: Sargramostim, PROCEDURE: Therapeutic Conventional Surgery, DRUG: Thiotepa, DRUG: Topotecan Hydrochloride, DRUG: Vincristine Sulfate
Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, Neuroblastoma
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Show 161 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Albany Medical Center Albany, New York | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CancerCare Manitoba Winnipeg, Manitoba | |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Hospital for Sick Children Toronto, Ontario | |
| IWK Health Centre Halifax, Nova Scotia | |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Kingston Health Sciences Centre Kingston, Ontario | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Michigan State University East Lansing, Michigan | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center -San Diego San Diego, California | |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tufts Children's Hospital Boston, Massachusetts | |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne State University/Karmanos Cancer Institute Detroit, Michigan | |
| West Virginia University Healthcare Morgantown, West Virginia | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study (STOP PIV)
Lisa Li - lli@ansunbiopharma.com
Miller, Kristin, B.
NCT03808922
HM20016591
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Inclusion Criteria:
• At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
• Immunocompromised, as defined by one or more of the following: * Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past * Received a solid organ transplant at any time in the past * Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past * Has an immunodeficiency due to congenital abnormality (only applicable to subjects age \< 18 years old) or pre-term birth (only applicable to subjects age ≤ 2 years old)
• Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
• If female, subject must meet one of the following conditions: * Not be of childbearing potential or * Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception
• Non-vasectomized males are required to practice effective birth control methods
• Capable of understanding and complying with procedures as outlined in the protocol
• Provides signed informed consent prior to the initiation of any screening or study-specific procedures For COVID-19 sub study:
• Be ≥18 years of age
• Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
• Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
• Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
• Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
• Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study
Exclusion Criteria:
• Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment
• Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for \>1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded
• Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
• Subjects taking any other investigational drug used to treat pulmonary infection.
• Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance
• Subjects with known hypersensitivity to DAS181 and/or any of its components
• Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria: * Has evidence of vital organ failure outside of the lung (e.g., liver, kidney) * Requires vasopressors to maintain blood pressure For COVID-19 sub study:
• Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.
• Subjects receiving any other investigational or empiric treatment for SARS-2-CoV (either as part of a clinical trial or under emergency approval (approved agents for the management of symptoms, e.g., fever, are permitted).
• Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)
• Subjects who are currently taking immunomodulating biologics (e.g, interferons, interleukin)
• Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection and meeting at least one of the following criteria: * Have evidence of vital organ failure outside of the lung (e.g., liver, kidney) * Require vasopressors to maintain blood pressure
• Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study
DRUG: DAS181, DRUG: Placebo, DRUG: DAS181 COVID-19, DRUG: DAS181 OL
Lower Respiratory Tract Infection, Parainfluenza, Immunocompromised, COVID-19
Parainfluenza, PIV, Immunocompromised, Lower Respiratory Tract Infection, LRTI, COVID19, SARS-CoV-2, Coronavirus, Ansun
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Show 67 locations
Study Locations
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| Location | Contacts |
|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | |
| Asan Medical Center Seoul, | |
| Baylor College of Medicine Houston, Texas | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| Children's Hospital Colorado Aurora, Colorado | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| City of Hope cancer Center Duarte, California | |
| Cook Children's Fort Worth, Texas | |
| Duke University Durham, North Carolina | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | |
| Froedtert Medical College Pulmonary Clinic Milwaukee, Wisconsin | |
| Hopital Henri Mondor Paris, | |
| Houston Methodist Hospital Houston, Texas | |
| Houston Methodist Hospital Houston, Texas | |
| Kent Hospital Warwick, Rhode Island | |
| Louisiana State University Shreveport, Louisiana | |
| Loyola University Medical Center Maywood, Illinois | |
| MD Anderson Houston, Texas | |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| National Cheng Kung University Hospital Tainan City, TNN | |
| National Taiwan University Hospital Taipei, | |
| Novant Health Charlotte, North Carolina | |
| Oregon Health & Science University Portland, Oregon | |
| Peter MacCallum Cancer Centre Melbourne, Victoria | |
| Prince of Wales Hospital Hong Kong, | |
| Rigshospitalet Copenhagen, | |
| Royal Melbourne Hospital Parkville, Victoria | |
| Samsung Medical Center Seoul, | |
| Seattle Children's Hospital Seattle, Washington | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| Seoul National University Hospital Seoul, Seoul Teugbyeolsi | |
| Shanghai Pulmonary Hospital Shanghai, Shanghai Municipality | |
| Shulan (Hangzhou) Hospital co., LTD Hangzhou, Zhejiang | |
| St. Elizabeth Youngstown Hospital Youngstown, Ohio | |
| Sylvester Comprehensive Cancer Center, University of Miami Health System Miami, Florida | |
| Texas Health Fort Worth, Texas | |
| The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, | |
| The Cleveland Clinic Foundation Cleveland, Ohio | |
| The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The Johns Hopkins Hospital Baltimore, Maryland | |
| The Lindner Center- The Christ Hospital Cincinnati, Ohio | |
| The Wesley Hospital Auchenflower, Queensland | |
| Therapeutic Concepts Houston, Texas | |
| UCLA Los Angeles, California | |
| UT Southwestern Medical Center Dallas, Texas | |
| University of California Davis Health System Sacramento, California | |
| University of California San Diego Medical Center La Jolla, California | |
| University of Chicago Chicago, Illinois | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Iowa Health Care Iowa City, Iowa | |
| University of Kansas Medical Center Fairway, Kansas | |
| University of Maryland Baltimore, Maryland | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Pittsburgh Medical Center Health System Pittsburgh, Pennsylvania | |
| Universtiy of Michigan Ann Arbor, Michigan | |
| VCU Health System Richmond, Virginia | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Washington University St Louis, Missouri | |
| Weill Cornell Medical College New York, New York | |
| West China Hospital Chengdu, | |
| Westmead Hospital Sydney, New South Wales |
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
Cady P Noda, Pharm.D. - cady.noda@vcuhealth.org
Noda, Cady, Ploessl
NCT03964259
HM20016430
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Inclusion Criteria:
• Diagnosis of lymphoma or acute lymphoblastic leukemia
• Candidate for a minimum of 2 cycles HDMTX (5 g/m2) in the inpatient setting
• Creatinine clearance ≥ 65 mL/min by modified Schwartz equation
• Patients of childbearing potential must have a negative pregnancy test (serum or urine)
• Lactating female patients must agree not to nurse a child while on this trial
• All patients and/or their parents or legal guardians must provide written informed consent, with assent provided if applicable
Exclusion Criteria:
• Trisomy 21
• History of dialysis within 30 days prior to study registration or currently on dialysis
• Polyuric renal dysfunction
• Pregnancy
• Known or suspected pleural effusion
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Drug: Intravenous fluids
Lymphoma, Acute Lymphoblastic Leukemia, Pediatric Cancer, Pediatric ALL, Pediatric Lymphoma
High Dose Methotrexate, HDMTX, Intravenous Fluids
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Show 1 location
Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond Richmond, Virginia | Lindsey B Gwaltney, RN - (lbgwaltney@vcu.edu) Cady P Noda, Pharm.D. - (cady.noda@vcuhealth.org) |
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Austin, Frances
NCT03067181
HM20015718
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Inclusion Criteria:
* There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \[all sites\])
* Standard risk 1: Patients must be \< 11 years of age at enrollment
* Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment
* Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).
* Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions:
* Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to \> 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided
* Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein \[AFP- ≥ 500 ng/mL or HCG ≥ 500 IU/L) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently
* Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor \[\< 3 mm\], but no other pathological evidence of MGCT); tumor markers: alpha-FP =\< 1,000 ng/mL, beta-HCG institutional normal; all ages
* Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
* Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
* Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification \[IGCCC\] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \< 11
* Standard risk 2 (SR2)
* Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \>= 11 and \< 25
* Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk; post op: alpha-FP \< 1,000 ng/mL, beta-HCG \< 5,000 IU/mL and lactate dehydrogenase (LDH) \< 3.0 x normal; age (years) \>= 11 and \< 25
* Notes:
* IGCCC criteria only apply to SR2 patients with a testicular primary tumor
* Use post-op tumor marker levels to determine IGCCC risk group
* Pure seminoma patients are not eligible for the standard risk arms of the study
* For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
* Adequate renal function defined as:
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR
* A serum creatinine based on age/sex as follows (within 7 days prior to enrollment): (mg/dL)
* 1 month to \< 6 months male: 0.4 female: 0.4
* 6 months to \< 1 year male: 0.5 female: 0.5
* 1 to \< 2 years male: 0.6 female: 0.6
* 2 to \< 6 years male: 0.8 female: 0.8
* 6 to \< 10 years male: 1 female: 1
* 10 to \< 13 years male: 1.2 female: 1.2
* 13 to \< 16 years: male: 1.5 female: 1.4
* \>= 16 years male: 1.7 female: 1.4
* Total bilirubin =\< 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
* Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN) (within 7 days prior to enrollment)
* Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
* Peripheral absolute neutrophil count (ANC) \>= 750/mm\^3 (within 7 days prior to enrollment) AND
* Platelet count \>= 75,000/mm\^3 (within 7 days prior to enrollment)
* Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
* Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes \[PROs\] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
* \>= 11 and \< 25 years old at enrollment
* Able to fluently speak and read English
* Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
* Followed for cancer or survivorship care at one of the following institutions:
* Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
* Dana Farber/Harvard Cancer Center
* Hospital for Sick Children
* Children's Hospital of Eastern Ontario
* Oregon Health and Science University
* Seattle Children's Hospital
* Yale University
Exclusion Criteria:
* Patients with any diagnoses not listed including:
* Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
* Pure ovarian or extragonadal dysgerminoma/seminoma
* Pure mature teratoma
* Pure immature teratoma with alpha-fetoprotein (AFP) \>= 1000 ng/mL
* "Poor risk" GCT (age \>= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or
* Primary central nervous system (CNS) germ cell tumor
* Germ cell tumor with somatic malignant transformation
* Spermatocytic seminoma
* Patients must have had no prior systemic therapy for the current cancer diagnosis
* Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain \[stage IV disease\] would be considered poor risk and therefore not eligible for this trial)
* Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\])
* Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\])
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\]) OTHER: Best Practice, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Bleomycin Sulfate, DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Etoposide, PROCEDURE: Magnetic Resonance Imaging, OTHER: Pharmacogenomic Study, PROCEDURE: Pulmonary Function Test, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma, Germ Cell Tumor, Malignant Germ Cell Tumor, Malignant Ovarian Teratoma, Stage I Ovarian Choriocarcinoma, Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage I Testicular Choriocarcinoma AJCC v6 and v7, Stage I Testicular Embryonal Carcinoma AJCC v6 and v7, Stage I Testicular Seminoma AJCC v6 and v7, Stage I Testicular Yolk Sac Tumor AJCC v6 and v7, Stage II Ovarian Choriocarcinoma, Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage II Testicular Choriocarcinoma AJCC v6 and v7, Stage II Testicular Embryonal Carcinoma AJCC v6 and v7, Stage II Testicular Yolk Sac Tumor AJCC v6 and v7, Stage III Ovarian Choriocarcinoma, Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage III Testicular Choriocarcinoma AJCC v6 and v7, Stage III Testicular Embryonal Carcinoma AJCC v6 and v7, Stage III Testicular Yolk Sac Tumor AJCC v6 and v7, Stage IV Ovarian Choriocarcinoma, Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7, Testicular Mixed Choriocarcinoma and Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Teratoma, Testicular Mixed Choriocarcinoma and Yolk Sac Tumor
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Study Locations
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| Location | Contacts |
|---|---|
| Addenbrookes Hospital-Medical School Cambridge, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| AdventHealth Littleton Littleton, Colorado | |
| AdventHealth Orlando Orlando, Florida | Site Public Contact - (FH.Cancer.Research@flhosp.org) |
| AdventHealth Parker Parker, Colorado | |
| AdventHealth Porter Denver, Colorado | |
| Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois | |
| Advocate Children's Hospital-Park Ridge Park Ridge, Illinois | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Albany Medical Center Albany, New York | |
| Alberta Children's Hospital Calgary, Alberta | Site Public Contact - (research4kids@ucalgary.ca) |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | |
| Alegent Health Lakeside Hospital Omaha, Nebraska | |
| Alegent Health Mercy Hospital Council Bluffs, Iowa | |
| Alfred I duPont Hospital for Children Wilmington, Delaware | Site Public Contact - (Allison.bruce@nemours.org) |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Anchorage Oncology Centre Anchorage, Alaska | |
| Anchorage Radiation Therapy Center Anchorage, Alaska | |
| Ann M Wierman MD LTD Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| Asante Rogue Regional Medical Center Medford, Oregon | |
| Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana | Site Public Contact - (research@stvincent.org) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | |
| Atrium Health Navicent Macon, Georgia | Site Public Contact - (andrew.weatherall@atriumhealth.org) |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beatson Oncology Center Glasgow, Scotland | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Bethesda North Hospital Cincinnati, Ohio | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| British Columbia Children's Hospital Vancouver, British Columbia | |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Broward Health Medical Center Fort Lauderdale, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| CARTI Cancer center Little Rock, Arkansas | Site Public Contact - (Research@CARTI.com) |
| CHI Health Good Samaritan Kearney, Nebraska | |
| CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas | |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, | |
| Camden Clark Medical Center Parkersburg, West Virginia | |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | |
| Cancer Care Specialists - Reno Reno, Nevada | |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | |
| Cancer Center at Saint Joseph's Phoenix, Arizona | |
| Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma | |
| Cancer Therapy and Integrative Medicine Las Vegas, Nevada | |
| Cancer and Blood Specialists-Henderson Henderson, Nevada | |
| Cancer and Blood Specialists-Shadow Las Vegas, Nevada | |
| Cancer and Blood Specialists-Tenaya Las Vegas, Nevada | |
| CancerCare Manitoba Winnipeg, Manitoba | Site Public Contact - (ctu_web@cancercare.mb.ca) |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carle Cancer Center Urbana, Illinois | |
| Carle Physician Group-Effingham Effingham, Illinois | |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | |
| Carle at The Riverfront Danville, Illinois | |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Cedars Sinai Medical Center Los Angeles, California | |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec | Site Public Contact - (yvan.samson@umontreal.ca) |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Chancellor Center for Oncology Newburgh, Indiana | |
| Chiba University Chiba-sgi, Chiba | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia | Site Public Contact - (Olivia.Floyd@choa.org) |
| Children's Hospital London, Ontario | |
| Children's Hospital Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital Of Eastern Ontario Ottawa, Ontario | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital at Montefiore The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Site Public Contact - (CancerTrials@email.chop.edu) |
| Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania | Site Public Contact - (jean.tersak@chp.edu) |
| Children's Hospital of San Antonio San Antonio, Texas | Site Public Contact - (bridget.medina@christushealth.org) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | Site Public Contact - (MACCCTO@mcw.edu) |
| Children's Hospital of the King's Daughters Norfolk, Virginia | Site Public Contact - (CCBDCresearch@chkd.org) |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota | Site Public Contact - (pauline.mitby@childrensmn.org) |
| Children's Mercy Hospitals and Clinics Kansas City, Missouri | Site Public Contact - (rryan@cmh.edu) |
| Children's National Medical Center Washington D.C., District of Columbia | Site Public Contact - (OncCRC_OnCall@childrensnational.org) |
| Christchurch Hospital Christchurch, | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | Site Public Contact - (cancer@cchmc.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center Wilmington, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Columbus Oncology and Hematology Associates Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Columbus Oncology and Hematology Associates Inc Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| CommonSpirit Cancer Center Mercy Durango, Colorado | |
| Commonwealth Cancer Center-Corbin Corbin, Kentucky | |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Covenant Children's Hospital Lubbock, Texas | Site Public Contact - (mbisbee@providence.org) |
| Creighton University Medical Center Omaha, Nebraska | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Deaconess Clinic Downtown Evansville, Indiana | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Desert West Surgery Las Vegas, Nevada | |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Essentia Health Cancer Center Duluth, Minnesota | |
| Flaget Memorial Hospital Bardstown, Kentucky | |
| Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington | |
| Fred and Pamela Buffett Cancer Center - Kearney Kearney, Nebraska | |
| Freeman Hospital Newcastle upon Tyne, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesis Healthcare System Cancer Care Center Zanesville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Glens Falls Hospital Glens Falls, New York | |
| Golisano Children's Hospital of Southwest Florida Fort Myers, Florida | Site Public Contact - (molly.arnstrom@leehealth.org) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Greater Regional Medical Center Creston, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Green Bay Oncology at Saint Vincent Hospital Green Bay, Wisconsin | John R. Hill - (Christy.Gilchrist@hshs.org) |
| HIMA San Pablo Oncologic Hospital Caguas, | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| HSHS Saint Nicholas Hospital Sheboygan, Wisconsin | Site Public Contact - (ewd_research_admin@hshs.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington | |
| Hematology and Oncology Consultants PC Omaha, Nebraska | |
| Henry Ford Health Saint John Hospital Detroit, Michigan | |
| Highline Medical Center-Main Campus Burien, Washington | |
| Hiroshima University Hospital Hiroshima, | |
| Hokkaido University Hospital Sapporo, Hokkaido | Site Public Contact - (hassi@med.hokudai.ac.jp) |
| Holy Family Memorial Hospital Manitowoc, Wisconsin | |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| Hospital for Sick Children Toronto, Ontario | Site Public Contact - (ask.CRS@sickkids.ca) |
| Hurley Medical Center Flint, Michigan | |
| Hyogo College of Medicine Nishinomiya, Hyogo, | |
| Hyogo Prefectural Kobe Children's Hospital Kobe, Hyōgo | Site Public Contact - (info_kch@hp.pref.hyogo.jp) |
| IU Health North Hospital Carmel, Indiana | |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | |
| Iowa Lutheran Hospital Des Moines, Iowa | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| Janeway Child Health Centre St. John's, Newfoundland and Labrador | Site Public Contact - (beverlyj.mitchell@easternhealth.ca) |
| Jefferson Abington Hospital Abington, Pennsylvania | |
| Jersey Shore Medical Center Neptune City, New Jersey | |
| Jewish Hospital Louisville, Kentucky | |
| Jewish Hospital Medical Center South Shepherdsville, Kentucky | |
| John H Stroger Jr Hospital of Cook County Chicago, Illinois | |
| John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales | |
| John Radcliffe Hospital Oxford, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Johns Hopkins All Children's Hospital St. Petersburg, Florida | Site Public Contact - (Ashley.Repp@jhmi.edu) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Kadlec Clinic Hematology and Oncology Kennewick, Washington | Site Public Contact - (research@kadlecmed.org) |
| Kaiser Permanente Downey Medical Center Downey, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | |
| Kaiser Permanente Washington Seattle, Washington | |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Capitol Hill Medical Center Washington D.C., District of Columbia | |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | |
| Kaiser Permanente-San Diego Mission San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kanagawa Children's Medical Center Yokohama, Kanagawa | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| Katmai Oncology Group Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Keio University Shinjuku-ku, Tokyo | |
| King Faisal Specialist Hospital and Research Centre Riyadh, | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Knox Community Hospital Mount Vernon, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Kokuritsu Seiiku Medical Research Center Hospital Tokyo, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Kyoto Perfectural University of Medicine Kyoto, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Kyushu Univeristy Higashiku, Fukuoka | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lake Huron Medical Center Port Huron, Michigan | |
| Lake Regional Hospital Osage Beach, Missouri | Site Public Contact - (clinicaltrials@lakeregional.com) |
| Las Vegas Cancer Center-Henderson Henderson, Nevada | |
| Las Vegas Cancer Center-Medical Center Las Vegas, Nevada | |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pebble Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Pecos Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | Site Public Contact - (research@smcrf.org) |
| Las Vegas Urology - Sunset Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Leeds General Infirmary Leeds, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Licking Memorial Hospital Newark, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Longmont United Hospital Longmont, Colorado | |
| Los Angeles General Medical Center Los Angeles, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California | |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marietta Memorial Hospital Marietta, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | |
| Mary Bridge Children's Hospital and Health Center Tacoma, Washington | Site Public Contact - (research@multicare.org) |
| Massachusetts General Hospital Cancer Center Boston, Massachusetts | |
| Mattel Children's Hospital UCLA Los Angeles, California | |
| Matthews Radiation Oncology Center Matthews, North Carolina | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| Memorial GYN Plus Ooltewah, Tennessee | |
| Memorial Health University Medical Center Savannah, Georgia | Site Public Contact - (Lorraine.OHara@hcahealthcare.com) |
| Memorial Hospital Marysville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Memorial Hospital Marysville, Ohio | |
| Memorial Hospital North Colorado Springs, Colorado | |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Hospital of South Bend South Bend, Indiana | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida | Site Public Contact - (OHR@mhs.net) |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri | |
| Mercy Cancer Center - Carmichael Carmichael, California | |
| Mercy Cancer Center - Elk Grove Elk Grove, California | |
| Mercy Cancer Center - Rocklin Rocklin, California | |
| Mercy Cancer Center - Sacramento Sacramento, California | |
| Mercy Cancer Center-West Lakes Clive, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Health - Perrysburg Hospital Perrysburg, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Anne Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Health - Saint Vincent Hospital Toledo, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Medical Center Springfield, Massachusetts | |
| Mercy Medical Center - Des Moines Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy Medical Center-West Lakes West Des Moines, Iowa | Site Public Contact - (cancerresearch@mercydesmoines.org) |
| Mercy San Juan Medical Center Carmichael, California | |
| Methodist Children's Hospital of South Texas San Antonio, Texas | Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Miami Cancer Institute Miami, Florida | |
| Michigan State University East Lansing, Michigan | |
| Midlands Community Hospital Papillion, Nebraska | |
| Miller Children's and Women's Hospital Long Beach Long Beach, California | |
| Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California | |
| Mission Hope Medical Oncology - Santa Maria Santa Maria, California | |
| Mission Hospital Asheville, North Carolina | Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monash Medical Center-Clayton Campus Clayton, Victoria | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Carmel East Hospital Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Grove City Hospital Grove City, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Carmel Health Center West Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Mountain Blue Cancer Care Center Golden, Colorado | |
| MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane, Washington | |
| MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane, Washington | |
| MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley, Washington | |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| NYU Langone Hospital - Long Island Mineola, New York | Site Public Contact - (cancertrials@nyulangone.org) |
| National Cancer Center Hospital Chuo-ku, Tokyo | Site Public Contact - (www-admin@ncc.go.jp) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Naval Medical Center - Portsmouth Portsmouth, Virginia | |
| Naval Medical Center -San Diego San Diego, California | |
| Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska | |
| Nemours Children's Clinic - Pensacola Pensacola, Florida | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| Nicklaus Children's Hospital Miami, Florida | |
| Niigata Cancer Centre Niigata, Chuo-ku | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| North Grove Medical Park Spartanburg, South Carolina | |
| North Shore Medical Center Skokie, Illinois | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois | |
| NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois | |
| NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois | |
| Northwest Medical Specialties PLLC Tacoma, Washington | |
| Norton Children's Hospital Louisville, Kentucky | Site Public Contact - (CancerResource@nortonhealthcare.org) |
| Novant Health Cancer Institute - Huntersville Huntersville, North Carolina | |
| Novant Health Cancer Institute - Matthews Matthews, North Carolina | |
| Novant Health Cancer Institute - Mooresville Mooresville, North Carolina | |
| Novant Health Cancer Institute - Rowan Salisbury, North Carolina | |
| Novant Health Presbyterian Medical Center Charlotte, North Carolina | Site Public Contact - (kashah@novanthealth.org) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | |
| OSF Saint Francis Medical Center Peoria, Illinois | |
| OSF Saint Francis Radiation Oncology at Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Marion General Hospital Marion, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth O'Bleness Hospital Athens, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Pickerington Methodist Hospital Pickerington, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Oncology Specialists of Charlotte Charlotte, North Carolina | |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Seven Hills Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Osaka City General Hospital Osaka, | |
| Overlake Medical Center Bellevue, Washington | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California | |
| Pacific Gynecology Specialists Seattle, Washington | |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Parkland Health Center-Bonne Terre Bonne Terre, Missouri | |
| Parkland Memorial Hospital Dallas, Texas | |
| PeaceHealth Saint John Medical Center Longview, Washington | Site Public Contact - (kmakin-bond@peacehealth.org) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | |
| PeaceHealth Southwest Medical Center Vancouver, Washington | |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Penrose-Saint Francis Healthcare Colorado Springs, Colorado | |
| Perth Children's Hospital Perth, Western Australia | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Princess Margaret Hospital for Children Perth, Western Australia | |
| Prisma Health Cancer Institute - Butternut Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Eastside Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Faris Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Greer Greer, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Seneca Seneca, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Prisma Health Greenville Memorial Hospital Greenville, South Carolina | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Cancer Institute Clackamas Clinic Clackamas, Oregon | |
| Providence Medical Foundation - Santa Rosa Santa Rosa, California | |
| Providence Newberg Medical Center Newberg, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Queen of The Valley Napa, California | |
| Providence Regional Cancer Partnership Everett, Washington | Site Public Contact - (marilyn.birchman@providence.org) |
| Providence Regional Cancer System-Aberdeen Aberdeen, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Centralia Centralia, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Lacey Lacey, Washington | Site Public Contact - (deidre.dillon@providence.org) |
| Providence Regional Cancer System-Shelton Shelton, Washington | |
| Providence Regional Cancer System-Yelm Yelm, Washington | |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California | Site Public Contact - (Najee.Boucher@providence.org) |
| Providence Saint Mary Regional Cancer Center Walla Walla, Washington | Site Public Contact - (Cheryl.Dodd@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Santa Rosa Memorial Hospital Santa Rosa, California | |
| Providence Willamette Falls Medical Center Oregon City, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Pulmonary Medicine Center of Chattanooga-Hixson Hixson, Tennessee | |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Radiation Oncology Associates Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Rocky Mountain Cancer Centers - Pueblo Pueblo, Colorado | |
| Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado | |
| Rocky Mountain Cancer Centers-Longmont Longmont, Colorado | |
| Rocky Mountain Cancer Centers-Parker Parker, Colorado | |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | |
| Rocky Mountain Cancer Centers-Thornton Thornton, Colorado | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rowan Regional Medical Center Salisbury, North Carolina | |
| Royal Children's Hospital Parkville, Victoria | Site Public Contact - (Jordan.Hansford@rch.org.au) |
| Royal Hospital for Children Glasgow, Scotland | Site Public Contact - (Randdsystems.PF1@ggc.scot.nhs.uk) |
| Royal Hospital for Children and Young People Edinburgh, Scotland | |
| Royal Manchester Children Hospital Manchester, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Royal Victoria Infirmary Newcastle, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Rush University Medical Center Chicago, Illinois | |
| Rush-Copley Healthcare Center Yorkville, Illinois | |
| Rush-Copley Medical Center Aurora, Illinois | |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Sacred Heart Hospital Pensacola, Florida | |
| Saint Ann's Hospital Westerville, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint Anthony Hospital Lakewood, Colorado | |
| Saint Bartholomew's Hospital London, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| Saint Clare Hospital Lakewood, Washington | |
| Saint Elizabeth Hospital Enumclaw, Washington | |
| Saint Elizabeth Regional Medical Center Lincoln, Nebraska | |
| Saint Francis Cancer Center Greenville, South Carolina | |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint James's University Hospital West Yorkshire, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saint John's Hospital Springfield, Illinois | Site Public Contact - (diana.weyhenmeyer@st-johns.org) |
| Saint Joseph Hospital Nashua, New Hampshire | |
| Saint Joseph Hospital East Lexington, Kentucky | |
| Saint Joseph London London, Kentucky | |
| Saint Joseph Mount Sterling Mount Sterling, Kentucky | |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | |
| Saint Joseph Regional Cancer Center Bryan, Texas | |
| Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida | Site Public Contact - (jennifer.manns@baycare.org) |
| Saint Joseph's Regional Medical Center Paterson, New Jersey | Site Public Contact - (HallL@sjhmc.org) |
| Saint Jude Children's Research Hospital Memphis, Tennessee | Site Public Contact - (referralinfo@stjude.org) |
| Saint Jude Midwest Affiliate Peoria, Illinois | |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary Corwin Medical Center Pueblo, Colorado | |
| Saint Mary's Medical Center West Palm Beach, Florida | |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Saint Michael Cancer Center Silverdale, Washington | |
| Saint Patrick Hospital - Community Hospital Missoula, Montana | Site Public Contact - (amy.hanneman@providence.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Saint Rita's Medical Center Lima, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Marinette Marinette, Wisconsin | |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Saints Mary and Elizabeth Hospital Louisville, Kentucky | |
| Saitama Children's Medical Center Chuo-ku, Saitama | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Saitama Medical University International Medical Center Hidaka-Shi, Saitama | |
| San Jorge Children's Hospital San Juan, | |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Scott and White Memorial Hospital Temple, Texas | |
| Seattle Children's Hospital Seattle, Washington | |
| Sheffield Children's Hospital Sheffield, | Site Public Contact - (r.innovation@nhs.net) |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Southeastern Medical Oncology Center-Clinton Clinton, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina | Site Public Contact - (jfields@cancersmoc.com) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Southern Ohio Medical Center Portsmouth, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Southern Oncology Specialists-Charlotte Charlotte, North Carolina | |
| Southern Oncology Specialists-Huntersville Huntersville, North Carolina | |
| Southwest Illinois Health Services LLP Swansea, Illinois | |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Spartanburg Medical Center - Mary Black Campus Spartanburg, South Carolina | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | |
| Stanford Cancer Institute Palo Alto Palo Alto, California | |
| Starship Children's Hospital Auckland, | |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| Strecker Cancer Center-Belpre Belpre, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Summerlin Hospital Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sunrise Hospital and Medical Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Sutter Medical Center Sacramento Sacramento, California | |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Cancer Institute-Issaquah Issaquah, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Ballard Campus Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-Cherry Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Swedish Medical Center-First Hill Seattle, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| Sydney Children's Hospital Randwick, New South Wales | |
| T C Thompson Children's Hospital Chattanooga, Tennessee | |
| Tampa General Hospital Tampa, Florida | Site Public Contact - (syapchanyk@tgh.org) |
| Tata Memorial Hospital Mumbai, Maharashtra | |
| Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas | |
| Texas Tech University Health Sciences Center-El Paso El Paso, Texas | |
| Texas Tech University Health Sciences Center-Lubbock Lubbock, Texas | |
| The Carle Foundation Hospital Urbana, Illinois | |
| The Children's Hospital at TriStar Centennial Nashville, Tennessee | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Don and Sybil Harrington Cancer Center Amarillo, Texas | |
| The Iowa Clinic PC West Des Moines, Iowa | |
| The Mark H Zangmeister Center Columbus, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| The Montreal Children's Hospital of the MUHC Montreal, Quebec | Site Public Contact - (info@thechildren.com) |
| The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York | |
| Tohoku University School of Medicine Sendai, Aoba-ku | Site Public Contact - (med-som@bureau.tohoku.ac.jp) |
| TriHealth Cancer Institute-Anderson Cincinnati, Ohio | |
| TriHealth Cancer Institute-Westside Cincinnati, Ohio | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Tripler Army Medical Center Honolulu, Hawaii | |
| Tufts Children's Hospital Boston, Massachusetts | |
| Tufts Medical Center Boston, Massachusetts | Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | |
| UCHealth Lone Tree Health Center Lone Tree, Colorado | |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California | |
| UCSF Benioff Children's Hospital Oakland Oakland, California | Site Public Contact - (cogbchoak@ucsf.edu) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa | |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa | |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa | |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa | |
| UMC Cancer Center / UMC Health System Lubbock, Texas | |
| UMass Memorial Medical Center - University Campus Worcester, Massachusetts | Site Public Contact - (cancer.research@umassmed.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| USA Health Strada Patient Care Center Mobile, Alabama | |
| USC / Norris Comprehensive Cancer Center Los Angeles, California | |
| USC Norris Oncology/Hematology-Newport Beach Newport Beach, California | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| United Hospital Center Bridgeport, West Virginia | |
| University Cancer Center Las Vegas, Nevada | |
| University College London Hospitals NHS Trust - Foley Street London, England | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University Hospital Torino, | Site Public Contact - (evelyn.swenson-britt@uhs-sa.com) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of Alberta Hospital Edmonton, Alberta | Site Public Contact - (pedsoncologyresearch@ahs.ca) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Chicago Comprehensive Cancer Center Chicago, Illinois | Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu) |
| University of Florida Health Science Center - Gainesville Gainesville, Florida | Site Public Contact - (cancer-center@ufl.edu) |
| University of Illinois Chicago, Illinois | |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kentucky/Markey Cancer Center Lexington, Kentucky | |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | Site Public Contact - (slusserb@med.umich.edu) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | Site Public Contact - (PennCancerTrials@careboxhealth.com) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Texas Health Science Center at San Antonio San Antonio, Texas | Site Public Contact - (phoresearchoffice@uthscsa.edu) |
| University of Tsukuba Hospital Tsukuba, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| University of Vermont Medical Center Burlington, Vermont | |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Johnson Creek Johnson Creek, Wisconsin | |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Valley Radiation Oncology Peru, Illinois | |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| WVUH-Berkely Medical Center Martinsburg, West Virginia | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Wayne Memorial Hospital Goldsboro, North Carolina | |
| Wesley Medical Center Wichita, Kansas | Site Public Contact - (WesleyResearch@wesleymc.com) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Charleston Division Charleston, West Virginia | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Westchester Medical Center Valhalla, New York | Site Public Contact - (ctsucontact@westat.com) |
| Western General Hospital Edinburgh, | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Western Illinois Cancer Treatment Center Galesburg, Illinois | |
| Weston Park Hospital Sheffield, | |
| Women's Cancer Center of Nevada Las Vegas, Nevada | |
| Woodland Memorial Hospital Woodland, California | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children (FSGS pediatric)
Ayaka Kitamura - Ayaka.Kitamura1@kaneka.co.jp
Lo, Megan
NCT02235857
HM20012146
Show full eligibility criteria
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Inclusion Criteria:
* A pediatric patient is deemed suitable for inclusion in the study if the patient has FSGS with a GFR ≥ 45 ml/min/1.73 m 2 and any of the following:
* Refractory nephrotic syndrome in which standard treatment options are unsuccessful (i.e., patient is unresponsive to standard corticosteroid and/or calcineurin inhibitor therapy for at least 8 weeks resulting in failure to achieve complete or partial remission);
* Refractory nephrotic syndrome in which standard treatment options are not well tolerated (i.e., patients intolerant to standard therapies due to severe side effects that negatively affect quality of life without providing an acceptable level of clinical benefit);
* Refractory or recurrent nephrotic syndrome in which standard therapy is contraindicated.
or
• Pediatric post renal transplant patients with nephrotic syndrome associated with primary FSGS.
Exclusion Criteria:
* General Exclusion Criteria
* Patient is greater than 21 years of age
* Parent or patient is unwilling or unable to sign and date the informed consent (Note: Only patients 18-21 years of age may sign the informed consent on their own behalf)
* Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of Liposorber® in pregnant women has not been studied. There may be unknown risks to an embryo/fetus. Sexually active women of child bearing potential should avoid pregnancy during the use of the Liposorber device and throughout the study duration.)
* Unable or unwilling to comply with the follow-up schedule
* Simultaneously participating in another investigational drug or device study
* Body weight \< 15 kg (33.1 lbs)
* Medical Exclusion Criteria
* Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.)
* Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., Angiotensin II receptor blockers (ARBs) that cannot be withheld on the day of apheresis until after the procedure
* Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis
* Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
* Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
* Extracorporeal circulation therapy with Liposorber® LA-15 System cannot be tolerated due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe uncontrollable hypotension
* Cardiac impairments such as uncontrolled arrhyth¬mia, unstable angina, decompensated congestive heart failure, or valvular disease
* Functional thyroid disease or liver abnormalities
* Unresolved systemic or local infection that could affect the clinical study outcomes DEVICE: LIPOSORBER® LA-15 System
Focal Segmental Glomerulosclerosis
pediatric, renal transplantation, recurrence, drug-resistant
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Show 12 locations
Study Locations
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| Location | Contacts |
|---|---|
| Akron Children's Hospital Akron, Ohio | Rupesh Raina, MD - (RRaina@chmca.org) Ann Pokelsek, BSN, RN, - (apokelsek@akronchildrens.org) |
| Cedars Sinai Medical Center Los Angeles, California | Ananth S Karumanchi - (SAnanth.Karumanchi@csmc.edu) |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | |
| Loma Linda University Children's Hospital Loma Linda, California | |
| Medical University of South Carolina Children's Hospital Charleston, South Carolina | Katherine E Twombley, MD - (twombley@musc.edu) |
| Nemours Children's Health Pensacola, Florida | |
| Nemours/A.I. duPont Hospital for Children Wilmington, Delaware | Joshua Zaritsky, MD PhD - (joshua.zaritsky@nemours.org) |
| St. Christopher's Hospital for Children Philadelphia, Pennsylvania | |
| University of Minnesota Minneapolis, Minnesota | Michelle Rheault, MD - (rheau002@umn.edu) |
| University of North Carolina Chapel Hill, North Carolina | Anne Froment - (anne_froment@med.unc.edu) |
| Weill Cornell Medical Center / NewYork-Presbyterian New York, New York | Eduardo M Perelstein, MD - (emperels@med.cornell.edu) |
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
Toll Free Number - Trialsites@merck.com
NCT03969901
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Inclusion Criteria:
• Requires hospitalization and treatment with IV antibacterial therapy for confirmed or suspected gram-negative bacterial infection (in the absence of meningitis), and is expected to require hospitalization through completion of IV study intervention, with at least 1 of the following primary infection types: HABP or VABP; cIAI; or cUTI.
• For Age Cohorts 4 and 5, participant is at least 37 weeks postmenstrual age at the time of signing the informed consent.
• If female, must not be pregnant or breastfeeding, and at least 1 of the following conditions must apply: must not be a woman of childbearing potential (WOCBP); OR, if a WOCBP, must agree to follow contraceptive guidance during the intervention period and for at least 24 hours after the last dose of study intervention.
• Has sufficient intravascular access to receive study drug through an existing peripheral or central line.
Exclusion Criteria:
• Is expected to survive less than 72 hours.
• Has a concurrent infection that would interfere with evaluation of response to the study antibacterials (IMI/REL or Active Control), including any of the following: endocarditis; osteomyelitis; meningitis; prosthetic joint infection; active pulmonary tuberculosis; disseminated fungal infection; concomitant infection at the time of randomization that requires non-study systemic antibacterial therapy in addition to IV study treatment or oral step-down therapy.
• Has HABP/VABP caused by an obstructive process, including lung cancer (or other malignancy metastatic to the lungs resulting in pulmonary obstruction) or other known obstruction.
• Has a cUTI, with any of the following: complete obstruction of any portion of the urinary tract (ie, requiring a permanent indwelling urinary catheter or instrumentation); documented ileal loop reflux; suspected or confirmed perinephric or intrarenal abscess; suspected or confirmed prostatitis, urethritis, or epididymitis; trauma to pelvis/urinary tract; presence of indwelling urinary catheter which cannot be removed at study entry.
• Has any of the following medical conditions at screening: history of a seizure disorder (requiring ongoing treatment with anti-convulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years); cystic fibrosis; history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to IMI, or to any carbapenem, cephalosporin, penicillin, or other β-lactam agent, or to other β-lactamase inhibitors (eg, tazobactam, sulbactam, clavulanic acid, avibactam).
• Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound study results, or interfere with the participant's participation for the full duration of the study.
• If less than 3 months of age, has received more than 72 hours of empiric antibacterial treatment until meningitis has been ruled out prior to initiation of IV study intervention.
• If 3 months of age or older, has received potentially therapeutic antibacterial therapy (eg, with gram-negative activity), including bladder infusions with topical urinary antiseptics or antibacterial agents, for a duration of more than 24 hours during the 48 hours preceding the first dose of study intervention.
• Is anticipated to be treated with any of the following medications: valproic acid or divalproex sodium (or has used valproic acid or divalproex sodium in the 2 weeks prior to screening) through 24 hours after completion of the final dose of IV study intervention for participants who receive IMI/REL or carbapenem; concomitant IV, oral, or inhaled antimicrobial agents with gram-negative activity, in addition to those designated in the study intervention groups, during the course of all (IV/oral) study intervention; planned receipt of suppressive/prophylactic antibiotics with gram-negative activity after completion of study intervention.
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to screening.
• Has enrolled previously in the current study and been discontinued, or has received REL for any other reason.
• Has an estimated creatinine clearance (based on the Cockcroft-Gault equation, for participants ≥12 years of age) or estimated glomerular filtration rate (eGFR, based on the modified Schwartz equation, for participants <12 years of age) below that specified for the appropriate age range; or requires peritoneal dialysis, hemodialysis, or hemofiltration.
• Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × upper limit of normal (ULN) at the time of screening. NOTE: Patients with acute hepatic failure or acute decompensation of chronic hepatic failure should also be excluded.
• Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
• Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Drug: IMI/REL, Drug: Active Control
Suspected or Documented Gram-negative Bacterial Infection
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Show 65 locations
Study Locations
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| Location | Contacts |
|---|---|
| Ankara Universitesi Tip Fakultesi. ( Site 0202) Ankara, | Study Coordinator |
| Banner University Medical Center ( Site 0356) Tucson, Arizona | |
| Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0290) Aguascalientes, | Study Coordinator |
| Chaim Sheba Medical Center ( Site 0190) Ramat Gan, Tel Aviv | Study Coordinator |
| Children s City Clinical Hospital 5 n.a. N.F. Filatov ( Site 0235) St. Petersburg, Sankt-Peterburg | |
| Children's City Clinical Hospital #1 ( Site 0237) Saint Petersburg, Sankt-Peterburg | |
| Children's Hospital of Richmond at VCU ( Site 0359) Richmond, Virginia | |
| Chris Hani Baragwanath Academic Hospital ( Site 0156) Johannesburg, Gauteng | Study Coordinator |
| Clinica de la Costa S.A.S. ( Site 0264) Barranquilla, Atlantico | Study Coordinator |
| Cukurova University Medical Faculty ( Site 0200) Adana, | Study Coordinator |
| Debreceni Egyetem Klinikai Kozpont ( Site 0100) Debrecen, Hajdu-Bihar | Study Coordinator |
| Ege Universitesi Tıp Fakultesi Hastanesi ( Site 0199) Izmir, | Study Coordinator |
| Empilweni Services and Research Unit ( Site 1557) Johannesburg, Gauteng | |
| Eskisehir Osmangazi University Medical ( Site 0201) Eskisehir, | Study Coordinator |
| Fundacion Hospital Infantil Universitario de San Jose ( Site 0268) Bogota, Distrito Capital De Bogota | Study Coordinator |
| Fundacion Hospital San Vicente de Paul ( Site 0269) Medellin, Antioquia | |
| Fundacion Valle del Lili ( Site 0266) Cali, Valle Del Cauca | Study Coordinator |
| Hadassah Ein Karem Hebrew University Medical Center ( Site 0188) Jerusalem, Yerushalayim | Study Coordinator |
| Haukeland Universitetssjukehus ( Site 0500) Bergen, Hordaland | Study Coordinator |
| Hippokration General Hospital of Thessaloniki ( Site 0244) Thessaloniki, | Study Coordinator |
| Hopital Francois Mitterand ( Site 0146) Dijon, Cote-d Or | |
| Hopital Jeanne de Flandre ( Site 0145) Lille, Nord-Pas-de-Calais | Study Coordinator |
| Hopitaux Pediatriques CHU Lenval ( Site 0143) Nice, Alpes-Maritimes | Study Coordinator |
| Hospital General de Tijuana ( Site 0284) Tijuana, Baja California | |
| Hospital Infantil Universitario Nino Jesus ( Site 0114) Madrid, | Study Coordinator |
| Hospital Universitario La Paz ( Site 0113) Madrid, | |
| Hospital Universitario Virgen del Rocio ( Site 0115) Sevilla, | Study Coordinator |
| Hospital del Nino y Adolescente Morelense ( Site 0286) Emiliano Zapata, Morelos | |
| Instituto Nacional de Pediatria ( Site 0291) Ciudad de Mexico, Distrito Federal | Study Coordinator |
| Instytut Centrum Zdrowia Matki Polki ( Site 0223) Lodz, Lodzkie | Study Coordinator |
| Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0131) Ivano-Frankivsk, Ivano-Frankivska Oblast | |
| Kharkiv City Children Hospital 16 ( Site 0130) Kharkiv, Kharkivska Oblast | |
| MHAT City Clinic Sv. Georgi EOOD ( Site 0167) Montana, | |
| MHAT Dr. Ival Seliminski ( Site 0173) Sliven, | |
| Miller Children's & Women's Hospital ( Site 0349) Long Beach, California | |
| Molotlegi Street ( Site 0155) Pretoria, Gauteng | Study Coordinator |
| Morozovskaya Children City Clinical Hospital ( Site 0241) Moscow, Moskva | |
| Municipal Enterprise Children's City Clinical Hospital in Poltava City Council ( Site 0122) Poltava, Poltavska Oblast | |
| PI Kryvorizka city clinical hospital 8 of Dnipropetrovsk Reg Council ( Site 0128) Kryvyy Rig, Dnipropetrovska Oblast | |
| Pan and Aglaia Kyriakou Children s Hospital ( Site 0247) Athens, Attiki | Study Coordinator |
| Pediatric Hematology Oncology and Immunology Centre n.a. D.Rogachev. ( Site 0233) Moscow, Moskva | |
| Philippine Children s Medical Center ( Site 0317) Quezon City, National Capital Region | |
| Rady Children's Hospital-San Diego ( Site 0347) San Diego, California | Study Coordinator |
| Rambam Medical Center ( Site 0189) Haifa, ?eif? | Study Coordinator |
| Regional Childrens Clinical Hospital ( Site 0400) Vologda, Vologodskaya Oblast | |
| SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 0198) Istanbul, | Study Coordinator |
| SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0121) Dnipro, Dnipropetrovska Oblast | |
| SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0226) Lomianki, Mazowieckie | Study Coordinator |
| Schneider Children's Medical Center ( Site 0187) Petah Tikva, HaMerkaz | |
| Smolensk Regional Clinical Hospital ( Site 0231) Smolensk, Smolenskaya Oblast | |
| Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0265) Bogota, Distrito Capital De Bogota | Study Coordinator |
| St.Petersburg State Pediatric Medical University ( Site 0236) Saint Petersburg, Sankt-Peterburg | |
| State Budgetary Healthcare Institution of Novosibirsk Region City Childrens Clinical Emergency Hospi Novosibirsk, Novosibirskaya Oblast | |
| Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0105) Nyiregyhaza, Szabolcs-Szatmar-Bereg | Study Coordinator |
| Tufts Medical Center-Floating Hospital for Children ( Site 0350) Boston, Massachusetts | |
| UMHAT Deva Maria. EOOD ( Site 0165) Burgas, | Study Coordinator |
| UMHAT Dr. Georgi Stranski EAD ( Site 0174) Pleven, | |
| UMHAT Kanev AD ( Site 0168) Ruse, | Study Coordinator |
| UMHAT Kanev AD ( Site 0169) Ruse, | Study Coordinator |
| University Hospital ( Site 0360) San Antonio, Texas | Study Coordinator |
| University of Athens - Aghia Sophia Childrens Hospital ( Site 0243) Athens, Attiki | Study Coordinator |
| University of New Mexico ( Site 0358) Albuquerque, New Mexico | |
| University of the Philippines-Philippine General Hospital ( Site 0318) Manila, National Capital Region | |
| West Virginia University Ruby Memorial Hospital ( Site 0344) Morgantown, West Virginia | Study Coordinator |
| Wojewodzki Szpital Zespolony im. Rydgiera ( Site 0220) Torun, Kujawsko-pomorskie | Study Coordinator |
A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)
Toll Free Number - Trialsites@merck.com
NCT03176134
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Inclusion Criteria:
• Has a parent/legally acceptable representative who is able to give documented informed consent
• Has ABSSSI, defined as ≥1 of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, or 3) wound infection
• Local symptoms of ABSSSI that started within 14 days before study start
• Suspected or documented Gram-positive bacterial infection
• Body weight ≥3.2 kg
Exclusion Criteria:
• Uncomplicated skin and skin structure infection
• ABSSSI due to or associated with disallowed etiology per protocol
• Received antibacterial therapy for treatment of the current episode of ABSSSI except 1) <48 hours of antibacterial therapy with a short-acting antibacterial drug, or 2) response is considered to be failure (no improvement in signs and symptoms) after at least 48 hours of therapy
• Known bacteremia, severe sepsis, or septic shock
• Significant or life-threatening condition, disease, or organ system condition
• Recent history of opportunistic infections where the underlying cause of the infection is still active, or is suspected to be at risk of opportunistic infection with unusual pathogens
• Received or is receiving treatment for active tuberculosis within 1 month of study start
• Known or suspected severe neutropenia
• Human immunodeficiency virus (HIV) positive and has Cluster of Differentiation (CD) 4 cell count <15% (HIV testing is not required for eligibility)
• Renal impairment that requires renal filtration
• Severe hepatic impairment
• Cardiac or electrocardiogram (ECG) finding that would limit participation in the study
• Received an investigational medicinal product (not approved) within 30 days before study start
• Investigational device present or removed within 30 days before study start
• Previously treated with tedizolid phosphate
• Contraindication, including hypersensitivity to tedizolid phosphate, other oxazolidinones, or any component in the formulation
• Contraindication, including hypersensitivity to all available comparator drugs
• Wound infection and history of hypersensitivity to aztreonam adjunctive therapy or metronidazole adjunctive therapy, if adjunctive therapy is required
• Needs oral administration of methotrexate, topotecan, irinotecan, or rosuvastatin, during administration of oral study drug (administration during the follow-up period, ie, after the EOT visit, is allowed, as is administration during treatment with IV drug)
• Female who is pregnant or nursing or is of childbearing potential and not abstinent; or male who is not abstinent
• Use of monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors, or serotonin 5-hydroxytryptamine receptor agonists (triptans)
• Identified as having used illicit drugs (urine drug screening not required for entry)
Drug: Tedizolid phosphate, Drug: Comparator
Acute Bacterial Skin and Skin Structure Infections
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Show 58 locations
Study Locations
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| Location | Contacts |
|---|---|
| Ankara City Hospital-Infectious Disease and Clinical Microbiology ( Site 0359) Ankara, | Study Coordinator |
| Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129) Chicago, Illinois | |
| Baylor College of Medicine - Texas Children's Hospital ( Site 0107) Houston, Texas | |
| CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 0241) Gral Escobedo, Nuevo Leon | Study Coordinator |
| Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0239) Aguascalientes, | Study Coordinator |
| Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCL-CENTRO DE ESTUDOS E PESQUISAS EM MOLES Natal, Rio Grande Do Norte | Study Coordinator |
| Children s Republican Clinical Hospital ( Site 0512) Kazan, Tatarstan, Respublika | |
| Children's Hospital of Michigan ( Site 0100) Detroit, Michigan | |
| Children's Hospital of Richmond at VCU ( Site 0123) Richmond, Virginia | |
| City Childrens Clinical Emergency Hospital ( Site 0507) Novosibirsk, Novosibirskaya Oblast | |
| Clinica Privada ( Site 0551) Guatemala, | Study Coordinator |
| Cook Children's Medical Center ( Site 0124) Fort Worth, Texas | |
| Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0353) Adana, | Study Coordinator |
| Daugavpils Regional Hospital ( Site 0651) Daugavpils, | Study Coordinator |
| Dnipropetrovsk Oblast Children's Clinical Hospital ( Site 0868) Dnipro, Dnipropetrovska Oblast | |
| Ege UTF ( Site 0356) Izmir, | Study Coordinator |
| Emmed Research Incorporating ( Site 0377) Pretoria, Gauteng | |
| Enhancing Care Foundation-DICRS ( Site 0381) Durban, Kwazulu-Natal | Study Coordinator |
| Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0351) Ankara, | |
| Haunersches Kinderspital ( Site 0480) München, Bayern | Study Coordinator |
| Hospital Civil Fray Antonio Alcalde-pediatrics infectious diseases ( Site 0230) Guadalajara, Jalisco | Study Coordinator |
| Hospital Infantil de Mexico Federico Gomez ( Site 0227) Mexico City, Distrito Federal | Study Coordinator |
| Hospital Pequeno Principe ( Site 0276) Curitiba, Parana | Study Coordinator |
| Hospital of Lithuanian University of Health Sciences Kaunas ( Site 0701) Kaunas, | Study Coordinator |
| Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277) Recife, Pernambuco | Study Coordinator |
| Instituto D'Or de Pesquisa e Ensino (IDOR)-Hospital São Luiz Jabaquara ( Site 0283) Sao Paulo, | Study Coordinator |
| Instituto Nacional de Pediatria ( Site 0231) Mexico City, Distrito Federal | Study Coordinator |
| Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0355) Istanbul, | Study Coordinator |
| Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0865) Ivano-Frankivsk, Ivano-Frankivska Oblast | |
| JSC Evex Hospital ( Site 0602) Tbilisi, | Study Coordinator |
| JSC Evex Hospitals ( Site 0603) Tbilisi, | Study Coordinator |
| JSC Evex Hospitals. ( Site 0601) Batumi, Ajaria | Study Coordinator |
| Klaipedos Vaiku Ligonine ( Site 0700) Klaipeda, | Study Coordinator |
| Liepaja Regional Hospital ( Site 0652) Liepaja, Liep?ja | Study Coordinator |
| MBAL Medica Ruse EOOD ( Site 0336) Ruse, | |
| MHAT City Clinic Sv. Georgi EOOD ( Site 0334) Montana, | Study Coordinator |
| MHAT Dr. Stamen Iliev AD ( Site 0339) Montana, | Study Coordinator |
| MHAT Sv. Nikolay Chudotvorets EOOD ( Site 0338) Lom, Montana | Study Coordinator |
| Osmangazi UTF ( Site 0357) Eskisehir, | Study Coordinator |
| Private Practice Dra. Manrique ( Site 0553) Guatemala, | |
| Private Practice Mario Melgar ( Site 0552) Guatemala, | Study Coordinator |
| Rady Children's Hospital-San Diego ( Site 0118) San Diego, California | |
| SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0863) Dnipro, Dnipropetrovska Oblast | |
| SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0431) Lomianki, Mazowieckie | |
| Setshaba Research Centre ( Site 0378) Pretoria, Gauteng | |
| Sisli Hamide Etfal Egitim ve Arastirma Hastanesi ( Site 0358) Istanbul, | Study Coordinator |
| Smolensk Regional Clinical Hospital ( Site 0511) Smolensk, Smolenskaya Oblast | |
| St. Louis Children's Hospital ( Site 0127) Saint Louis, Missouri | |
| Tbilisi State Medical University G. Zhvania Pediatric Academic Clinic ( Site 0600) Tiblisi, Tbilisi | Study Coordinator |
| UMHAT Deva Maria ( Site 0333) Burgas, | Study Coordinator |
| UMHAT Dr. Georgi Stranski EAD ( Site 0330) Pleven, | Study Coordinator |
| UMHAT Kanev AD ( Site 0337) Ruse, | Study Coordinator |
| UMHAT Sv. Georgi ( Site 0332) Plovdiv, | |
| UMHATEM. N.I.Pirogov. EAD ( Site 0331) Sofia, | |
| Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0702) Vilnius, | Study Coordinator |
| William Beaumont Hospital ( Site 0108) Royal Oak, Michigan | |
| Wojewodzki Szpital Obserwacyjno Zakazny ( Site 0429) Bydgoszcz, Kujawsko-pomorskie | |
| Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 0427) Lodz, Lodzkie |
The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant (MODULAATE)
Trial Registration Coordinator - clinicaltrials@cslbehring.com
NCT03805789
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Inclusion Criteria:
• Male or female subjects, ?12 years of age (? 18 years of age for subjects at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome and myeloproliferative neoplasms
• Planned myeloablative conditioning regimen
Exclusion Criteria:
• Prior autologous or allogeneic HCT
• T-cell depleted transplant or planned use of anti-T cell antibody therapy either ex vivo or in vivo (ie, anti-thymocyte globulin [ATG], alemtuzumab) for GVHD prophylaxis
• Planned umbilical cord blood (UCB) transplant
Biological: Alpha-1 antitrypsin (AAT), Biological: Placebo
Acute-graft-versus-host Disease
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Show 17 locations
Study Locations
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| Location | Contacts |
|---|---|
| Centennial Medical Center Nashville, Tennessee | use central contact |
| Cleveland Cancer Center Cleveland, Ohio | Use Central Contact |
| Complejo Hospitalario de Navarra Pamplona, | Use Central Contact |
| Duke University Medical Center Durham, North Carolina | Use Central Contact |
| Emory University Atlanta, Georgia | Use Central Contact |
| Hospital Regional Universitario de Malaga Málaga, | Use Central Contact |
| Hospital Universitario Marqu Santander, | Use Central Contact |
| Hospital Universitario Vall d' Barcelona, | Use Central Contact |
| Johns Hopkins Hospital Baltimore, Maryland | Use Central Contact |
| Mount Sinai Medical Center Miami Beach, Florida | Use Central Contact |
| Royal Brisbane and Women's Hospital Brisbane, Queensland | Use Central Contact |
| Scottsdale HH Cancer Transplant Scottsdale, Arizona | Use central contact |
| Seattle Cancer Care Alliance Seattle, Washington | Use Central Contact |
| Texas Transplant Institute San Antonio, Texas | Use Central Contact |
| Universitario de Salamanca Salamanca, | Use Central Contact |
| University of Michigan Ann Arbor, Michigan | Use Central Contact |
| Virginia Commonwealth University Richmond, Virginia | Use Central Contact |