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631 Study Matches

In-Home Adjustment of New Spinal Cord Injury Caregivers

Perrin, Paul, B - pperrin@vcu.edu

Perrin, Paul, B
N/A
NCT03244098
HM20009566
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Inclusion Criteria:
SCI Patient
Inclusion Criteria:

• have a telephone in the home or cellular phone and are able to talk on the phone in English
• are able to provide informed consent
• demonstrate a clinician-rated loss in motor/sensory function on the ASIA scale (i.e., have a spinal cord injury) Caregiver
Inclusion Criteria:

• have a telephone in the home or cellular phone and are able to talk on the phone in English
• are able to provide informed consent
• are a primary caregiver of the individual with SCI
• Caregivers with scores below 10 on the literacy screen will identify a family member or friend to review the guidebook with the caregiver. If no one is identified, the TAP clinician will review the materials with the caregiver and function in that additional capacity
Exclusion Criteria:

• individual with SCI receives his/her primary care from a professional caregiver or other individual outside of the household besides the primary caregiver
• individuals with SCI or caregivers with known current uncontrolled substance dependence, aphasia, anosognosia (deficit in self-awareness), or treatment due to known self-inflicted injury
• individuals living alone
• prisoners
• SCI patient without decision making capacity to consent
Behavioral: Transition Assistance Program
Spinal Cord Injuries, External Causes of Injury and Poisoning (800-999)
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Virginia Commonwealth University Richmond, Virginia

Genome Transplant Dynamics (GTD NIH)

Sean T Agbor-Enoh, M.D. - agborenohst@mail.nih.gov

Shah, Keyur, B
N/A
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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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

Myocardial Ischemia and Transfusion (MINT)

Jeffrey L Carson, MD - Jeffrey.Carson@Rutgers.edu

Kontos, Michael, C
Phase 3
NCT02981407
HM20010218
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Inclusion Criteria:

• 18 years of age or older
• Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
• Hemoglobin concentration less than 10 g/dL at the time of random allocation
• Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient
Exclusion Criteria:

• Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
• Decline blood transfusion
• Scheduled for cardiac surgery during the current admission
• Receiving only palliative treatment
• Known that follow-up will not be possible at 30 days
• Previously participated in MINT
• Currently enrolled in a competing study that interferes with the intervention or follow-up of MINT or enrolled in a competing study that has not been approved by the local Institutional Review Board
• Patient physician does not believe the patient is an appropriate candidate for the trial
Biological: Red Blood Cell Transfusion
Myocardial Infarction, Anemia
Red Blood Cell Transfusion, Anemia, Heart Disease, Cardiovascular Disease
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Study Locations

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Location Contacts
AMITA Health Hinsdale, Illinois
Albany Medical College Albany, New York
Alexian Brothers Medical Center Elk Grove Village, Illinois
Auckland City Hospital Grafton, Auckland
Aultman Hospital Canton, Ohio Jeannie Archinai
Baylor St Luke's Medical Center Houston, Texas
Beth Israel Deaconess Medical Center Boston, Massachusetts
Boston Medical Center Boston, Massachusetts
CH Chartres - Chartres Chartres,
CHRU Tours -Hôpital Trousseau Chambray-lès-Tours,
CHU Arnaud de Villeneuve - Montpellier Montpellier,
CHU Nancy Nancy,
CHU Poitiers - Poitiers Poitiers,
CHU le Bocage - Dijon Dijon,
Central Arkansas Veterans Healthcare System Little Rock, Arkansas
Centre Hosp. Universitaire de Montréal Montréal, Quebec
Centre Hospitalier Sud Francilien Corbeil-Essonnes,
Centre Hospitalier Universitaire de Lille Lille,
Centre Hospitalier Universitaire de Sherbrooke Sherbrooke, Quebec
Christchurch Hospital Christchurch,
Concord Repatriation General Hospital Concord,
Copper University Hospital Camden, New Jersey
Danbury Hospital Danbury, Connecticut
Durham Va Durham, North Carolina
Essentia Health Duluth, Minnesota
Flinders Medical Centre Bedford Park, South Australia
Foothills Medical Centre Calgary,
General Hospital Trois-Rivièrs Trois-Rivières, Quebec
Gisborne Hospital Gisborne,
Gosford Hospital Gosford,
Greenville Health System Greenville, South Carolina
Grey Nuns Community Hospital Edmonton, Alberta
Hackensacjk University Medical Center Hackensack, New Jersey
Hamilton Health Sciences Hamilton, Ontario
Hamilton St. Joseph's Health Hamilton, Ontario
Hopital Charles LeMoyne Greenfield Park, Quebec
Hopital Europeen Georges-Pompidou Paris,
Hopital Haut Leveque Pessac,
Hopital La Pitie Salpetriere Paris,
Hopital Pasteur Nice,
Hopital Rangueil Toulouse,
Hospital Agamenon Magalhães Recife, Pernambuco
Hospital Cárdio Pulmonar Salvador, Bahia
Hospital Felício Rocho Belo Horizonte, Minas Gerais
Hospital Maternidade e Pronto Socorro Santa Lucia Poços de Caldas, Minas Gerais
Hospital São Paulo São Paulo,
Hospital Universitário Professor Edgard Santos Salvador,
Hospital Vera Cruz Campinas,
Hospital das Clinicas da UFU Uberlândia,
Hospital de Base de Rio Preto São José Do Rio Preto, São Paulo
Hospital de Base de Rio Preto São José Do Rio Preto, São Paulo
Hospital de Clínicas da UFTM Uberaba,
Hotel-Dieu de Levis Lévis, Quebec
Hôpital BICHAT- APHP Paris,
Hôpital Charles Nicolle- Rouen Rouen,
Hôpital Lariboisière Paris,
Hôpital Universitaire Carémeau (CHU Carémeau) Nîmes,
Instituto Orizonti Belo Horizonte,
Instituto de Cardiologia do RS Porto Alegre,
Instituto de Ensino e Pesquisa do Hospital da Bahia Salvador, Estado de Bahia
Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil Brasília,
Jersey Shore University Medical Neptune, New Jersey
Jewish General Hospital Montreal, Quebec
La Tronche Hôpital Michallon La Tronche,
Lahey Hospital Burlington, Massachusetts
Lancaster General Hospital Lancaster, Pennsylvania
Lankenau Medical Center Wynnewood, Pennsylvania
Lenox Hilll Hospital New York, New York
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic Rochester, Minnesota
Medical College of Wisconsin - Froedtert Hospital Milwaukee, Wisconsin Barbara Shimada-Krouwer, RN BSB
Memorial Hospital at Gulfport Gulfport, Mississippi
Minneapolis Heart Institute (Foundation) Minneapolis, Minnesota
Montefiore Medical Center The Bronx, New York
Montreal General Hospital Montreal, Quebec
NYP Brooklyn Methodist Brooklyn, New York
NYU Langone Medical Center, Bellevue Hospital New York, New York
Nelson Hospital Nelson,
New York Presbyterian/Queens Flushing, New York
North Shore University Hospital Manhasset, New York
Northern Westchester Hospital Mount Kisco, New York
Northwell Staten Island Hopsital Staten Island, New York
PENN Presbyterian Medical Cente Philadelphia, Pennsylvania
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE Recife,
QE II Health Sciences Center Halifax, Nova Scotia
Quebec Heart and Lung Institute Quebec,
Regina General Hospital Regina, Saskatchewan
Rhode Island Hospital Providence, Rhode Island
Robert Wood Johnson University Hospital New Brunswick, New Jersey Jeffrey L Carson, MD - (jeffrey.carson@rutgers.edu)
Rochester General Hospital Rochester, New York
Royal Alexandra Hospital Edmonton, Alberta
Royal Columbian Hospital New Westminster, British Columbia
Royal Perth Hospital Perth, Western Australia
Royal Victoria Hospital Montréal, Quebec
Rush University Medical Center Chicago, Illinois
Saint Luke's Mid America Heart Kansas City, Kansas
Santa Casa de Marília Cascata,
Sociedade Hospitalar Angelina Caron Centro,
Southside Hospital Bay Shore, New York
St. Boniface General Hospital Winnipeg, Manitoba
St. Joseph Mercy Health System Ypsilanti, Michigan
St. Joseph's Health Centre Hamilton, Ontario
St. Michael's Hospital Toronto, Ontario
Stony Brook Medicine Stony Brook, New York
Sunnybrook Health Sciences Centre Toronto, Ontario
Surrey Memorial Hospital Surrey, British Columbia
Taranaki Hospital New Plymouth,
The Memphis VAMC Memphis, Tennessee
The Miriam Hospital Providence, Rhode Island
The University of North Carolina at Chapel Hill Chapel Hill, North Carolina
Thomas Jefferson University Philadelphia, Pennsylvania
Tulane University School of Medicine New Orleans, Louisiana
University Hospital - LHSC London, Ontario
University of Alberta Hospital Edmonton, Alberta
University of Arkansas Medical Sciences (UAMS) Hospital Little Rock, Arkansas
University of Chicago Medical Center Chicago, Illinois Mary Harris-Moreno
University of Louisville Louisville, Kentucky
University of Michigan Ann Arbor, Michigan
University of Minnesota Medical Center Fairview Minneapolis, Minnesota
University of New Mexico Albuquerque, New Mexico
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania
University of Rochester Rochester, New York
University of Toledo Medical Center Toledo, Ohio
University of Vermont Medical Center Burlington, Vermont
VAGLAHS Los Angeles, California
Vancouver General Hospital Vancouver, British Columbia
Victoria Heart Institute Victoria, Ontario
Victoria Hospital - LHSC London, Ontario
Virginia Commonwealth University Richmond, Virginia
WakeMed Health and Hospital Raleigh, North Carolina
Washington University St Louis, Missouri
Westchester Medical Center Valhalla, New York
Whangarei Hospital Whangarei,

SynCardia 70cc TAH-t for Destination Therapy (DT) (RA-540)

Judy Skroback, CIP, CRCP - jskroback@syncardia.com

Medalion, Benjamin
N/A
NCT02232659
HM20004553
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Primary Arm
Inclusion Criteria:

• Patients with ife-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 4)
• Ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies [PRAs]) as determined by the implanting center at time of implant screening assessment.
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Ambulatory without assistance
• Patients between 19 and 75 years of age
• Patients with Body Surface Area (BSA) of ? 1.7m2
• Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion Criteria:

• Cardiac transplant-eligible patients
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient space in the chest
• Patients on ECMO support
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Acute or Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with cardiac cachexia (e.g., pre-albumin <17, fragility, and catabolic/anabolic imbalance)
• Patients with a comorbidity that has a poor prognosis of survival beyond six months
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator) Secondary Arm
Inclusion Criteria:

• Patients who are NOT eligible to participate in the Primary Arm
• Patients with life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 7)
• Ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Patients 19 years of age or older
• Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion Criteria:

• Patients who are less than 19 years old
• Cardiac transplant-eligible patients
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with insufficient space in the chest
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
Device: 70cc TAH-t for Destination Therapy
Life-threatening, Biventricular Heart Failure, Ineligible for Cardiac Transplant
SynCardia, Total Artificial Heart, Biventricular heart failure, Ineligible for cardiac transplant
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Study Locations

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Banner University Medical Center Phoenix, Arizona
Banner University Medical Center Phoenix Phoenix, Arizona
Cedars-Sinai Medical Center Los Angeles, California
Froedtert & the Medical College of Wisconsin Milwaukee, Wisconsin
Integris Baptist Medical Center Oklahoma City, Oklahoma
Memorial Hermann Hospital Houston, Texas
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.
N/A
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 Angles, 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
N/A
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.
N/A
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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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, Saskatchewan
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 Grafton, 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.
N/A
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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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 Herston, 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 Centralia, Illinois 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, Saskatchewan
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 Grafton, 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
N/A
NCT00097292
HM20012389
Endocrine, Nutritional And Metabolic Diseases, And Immunity Disorders, Endocrine, Nutritional, Metabolic Diseases, Immunity Disorders (240-279)
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Virginia Commonwealth University Richmond, Virginia Memoli, Erica, H - (erica.memoli@vcuhealth.org)

Change in Vaginal Length & Sexual Function in Women Who Undergo Surgery ? RT for Endometrial Cancer

Dodson, Patricia, RN, BSN, CCRC - pwdodson@vcu.edu

Dodson, Patricia, RN, BSN, CCRC
NA
10921
HM20004634
Modality: Radiotherapy
Corpus Uteri
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Virginia Commonwealth University Richmond, Virginia Dodson, Patricia, RN, BSN, CCRC - (pwdodson@vcu.edu)

Study of the Natural History of HCC and its Diagnostic, Prognostic Variables and Treatment Outcomes

Lee, Hannah, M. - hannah.lee@vcuhealth.org

Lee, Hannah, M.
N/A
12587
HM20007405
Liver
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Virginia Commonwealth University Richmond, Virginia Lee, Hannah, M.D. - (hannah.lee1@vcuhealth.org)

Radiotherapy for Early Stage Palmar and Plantar Fibromatosis

Loyall, Pamela - ployall@vcu.edu

Weiss, Elisabeth
N/A
10906
HM14042
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Virginia Commonwealth University Richmond, Virginia Williamson, Daeryl, RN - (johnsondl4@vcu.edu)

Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women

Benotsch, Eric, G - ebenotsch@vcu.edu

Benotsch, Eric, G
Pilot
13748
HM20011245
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Virginia Commonwealth University Richmond, Virginia Benotsch, Eric, Ph.D. - (ebenotsch@vcu.edu)

Detection of Urinary Bladder Cancer Using Raman Spectroscopy-Based Screening of Urine

Guruli, Georgi - georgi.guruli@vcuhealth.org

Guruli, Georgi
N/A
12588
HM20006879
Other Urinary, Bladder, Unknown Sites, Kidney, Prostate, Urinary Bladder
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Virginia Commonwealth University Richmond, Virginia Guruli, Georgi, M.D., Ph.D. - (georgi.guruli@vcuhealth.org)

Molecular Characterization of Lung Tumors

Deb, Sumitra - sdeb@vcu.edu

Deb, Sumitra
N/A
11995
HM20006524
Lung
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Virginia Commonwealth University Richmond, Virginia

Southern Virginia Living Well Research and Registry (VLWR)

Thomson, Maria - mthomson2@vcu.edu

Sheppard, Vanessa, B.
N/A
14020
HM20012418
Any Site
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Virginia Commonwealth University Richmond, Virginia Thomson, Maria, Ph.D. - (mthomson2@vcu.edu)

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
N/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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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 Durango, Colorado
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

Skeletal Muscle Hypertrophy and Cardio-Metabolic Benefits after Spinal Cord Injury

Amos, Tiffany - tiffany.amos@vcuhealth.org

Carter, William, E
N/A
NCT02660073
HM20005018
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Virginia Commonwealth University Richmond, Virginia Amos, Tiffany - (tiffany.amos@vcuhealth.org)

A Longitudinal Observational Study of the Natural History and Management of Patients With HCC

Stephanie Harrison - sharrison@targetrwe.com

Lee, Hannah, M.
N/A
NCT02954094
HM20011686
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Inclusion Criteria:

• Male or female patients, age ≥18 years
• Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)
Exclusion Criteria:

• Inability to provide written informed consent
Hepatocellular Cancer
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A.O.U.P. di Palermo Palermo,
Banner University Medical Center Phoenix, Arizona
Baylor Scott & White All Saints Fort Worth, Texas
Beth Israel Deaconess Medical Center Boston, Massachusetts
Bon Secours Liver Institute of Virginia Richmond, Virginia
CHU de Nice - Hôpital L'Archet 2 Nice,
California Liver Research Institute Pasadena, California
Center for Liver Disease and Transplant at CMC Charlotte, North Carolina
Charite - Universitatsmedizin Berlin Berlin,
Clinica Universidad de Navarra Pamplona, Navarre
Clinical Research Institute@ Methodist Dallas Medical Center Dallas, Texas
Columbia University New York, New York
Complejo Hospitalario Universitario A Coruna A Coruña,
Emory University Hospital Atlanta, Georgia
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan,
Gastro Florida Clearwater, Florida
Georgetown University Washington D.C., District of Columbia
Harborview Medical Center Seattle, Washington
Henry Ford Health System Detroit, Michigan
Hospital Puerta de Hierro Majadahonda Madrid,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Politècnic La Fe Valencia,
Hospital Universitario Virgen del Rocio Seville,
Humanitas Mirasole IRCCS Rozzano,
Hôpitaux Universitaires Paris Centre Paris,
IRCCS "Casa Sollievo della Sofferenza" San Giovanni Rotondo,
Johns Hopkins University Baltimore, Maryland
Mayo Clinic Rochester, Minnesota
Medical University of South Carolina Charleston, South Carolina
Medizinische Hochschule hannover Hanover, Lower Saxony
Mercy Medical Center, GI Research Baltimore, Maryland
NYU Langone Health Brooklyn, New York
Northwell Health - Center for Liver Diseases Manhasset, New York
Northwestern University Division of Gastroenterology and Hepatology Chicago, Illinois
Penn State Hershey Medical Center Hershey, Pennsylvania
Piedmont Atlanta Hospital Atlanta, Georgia
Piedmont Cancer Institute Atlanta, Georgia
Providence Health & Services Cancer Clinical Trials Portland, Oregon
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 St Louis, Missouri
Schiff Center for Liver Diseases/University of Miami Miami, Florida
Southern Therapy and Advanced Research (STAR) LLC Jackson, Mississippi
Stanford University Palo Alto, California
Tampa General Medical Group Tampa, Florida
Tulane University Metairie, Louisiana
Universitatsklinikum Leipzig Leipzig, Saxony
Universitatsmedizin Mainz Mainz,
University of Arkansas Little Rock, Arkansas
University of California San Francisco, California
University of California-Davis Sacramento, California
University of Chicago Chicago, Illinois
University of Florida Health Gastroenterology Jacksonville, Florida
University of Florida Hepatology Research at CTRB Gainesville, Florida
University of Iowa Hospitals and Clinics Iowa City, Iowa
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 Southern California/Norris Comprehensive Cancer Center Los Angeles, California
University of Texas Southwestern Medical Center Dallas, Texas
University of Virginia Charlottesville, Virginia
University of Wisconsin Madison, Wisconsin
Universitätsklinikum Aachen Aachen,
Universitätsklinikum Düsseldorf Düsseldorf,
Universitätsklinikum Frankfurt Frankfurt,
Universitätsklinikum Magdeburg Magdeburg,
Vanderbilt University Medical Center - GI Research Office Nashville, Tennessee
Virginia Commonwealth University Richmond, Virginia
Weill Cornell Medical College New York, New York
Wenatchee Valley Hospital & Clinics Wenatchee, Washington

Cardiac Sarcoidosis Randomized Trial (CHASM-CS-RCT)

David H Birnie, MD - dbirnie@ottawaheart.ca

Kron, Jordana
PHASE3
NCT03593759
HM20014180
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Inclusion Criteria:
(i) Cardiac sarcoidosis presenting with one or more of the following clinical findings: * advanced conduction system disease (defined as Mobitz II AV block or third degree AV block) * significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias) * non- sustained or sustained ventricular arrhythmia * left ventricular dysfunction (LVEF \< 50%) * right ventricular dysfunction (RVEF \< 40%) AND (ii) No alternative explanation for clinical features AND (iii) Nuclear Imaging within six-months of enrollment consisting of FDG-PET scan with FDG uptake suggestive of active CS and myocardial perfusion imaging AND ONE OR BOTH OF FOLLOWING (iv) Positive biopsy for Sarcoid (either EMB or extra-cardiac) (v) CT Chest showing features consistent with pulmonary sarcoidosis and/or mediastinal and/or hilar lymphadenopathy
Exclusion Criteria:

• Current or recent (within two months) non-topical treatment for sarcoidosis
• Current Oral/IV treatment of duration greater than 5 days
• Currently taking Methotrexate or Prednisone for another health condition
• Intolerance or contra-indication to Methotrexate or Prednisone
• Patient does not meet all of the above listed inclusion criteria
• Patient is unable or unwilling to provide informed consent
• Patient is included in another randomized clinical trial
• Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia
• Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)
• Breastfeeding
• Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
• Patients for whom the investigator believes that the trial is not in the interest of the patient
DRUG: Prednisone or Prednisolone, DRUG: Methotrexate
Cardiac Sarcoidosis, Sarcoidosis
Cardiac Sarcoidosis, Prednisone (or Prednisolone), Methotrexate
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Allegheny General Hospital Pittsburgh, Pennsylvania Indu Poornima, MD - (indu.poornima@ahn.org)
CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont Sherbrooke, Quebec Felix Ayala-Paredes, MD - (felix.ayala-paredes@USherbrooke.ca)
CIUSSS-Hopital du Sacre-Coeur de Montreal Montreal, Quebec Leila Laroussi, MD - (liloularoussi@gmail.com)
Chiba University Chiba-sgi, Chiba
Eastern Health Health Sciences Centre St. John's, Newfoundland and Labrador Stephen Duffett, MD - (sduffett@mun.ca)
Hokkaido University Sapporo, Kita 8, Nishi 5, Kita-Ku Toshiyuki Nagai, MD - (nagai@med.hokudai.ac.jp)
Imperial College Healthcare Trust-NHS-Hammersmith Hospital London, Amanda Varnava, MD - (amanda.varnava@nhs.net)
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval Quebec City, Quebec Mario Senechal, MD - (Mario.Senechal@criucpq.ulaval.ca)
King's College Hospital NHS Foundation Trust London, Francis D Murgatroyd, MD - (francis.murgatroyd@nhs.net)
Libin Cardiovascular Institute of Alberta Calgary, Alberta Russell Quinn, MD - (frquinn@ucalgary.ca)
London Health Sciences Centre London, Ontario Nikolaos Tzemos, MD - (Niko.Tzemos@lhsc.on.ca)
Montefiore Medical Center The Bronx, New York Yogita Rochlani, MD - (yrochlani@montefiore.org)
Montreal Heart Institute Montreal, Quebec Genevieve Giraldeau, MD - (genevieve.giraldeau@umontreal.ca)
Nagoya City University Nagoya, K Nakasuka, MD - (kosuke.nakasuka@gmail.com)
National Cerebral and Cardiovascular Center (NCVC) Osaka, Kengo Kusano, MD - (kusanokengo@gmail.com)
Nippon Medical School Tokyo, Kenji Yodogawa, MD - (yodo@nms.ac.jp)
QE II Health Sciences Centre Halifax, Nova Scotia Doug Hayami, MD - (doug.hayami@nshealth.ca)
Sapporo Medical University Sapporo, Toshiyuki Yano, MD - (tyano@sapmed.ac.jp)
St. Joseph's Healthcare Centre Hamilton, Ontario Nathan Hambly, MD - (nathan.hambly@medportal.ca)
St. Marrianna University Kawasaki,
St. Paul's Hospital Vancouver, British Columbia Mustafa Toma, MD - (MToma@providencehealth.bc.ca)
The Ohio State University Wexner Medical Center Columbus, Ohio Steven Kalbfleisch, MD - (steven.kalbfleisch@osumc.edu)
Tufts Medical Center Boston, Massachusetts
University of Fukui Fukui,
University of Michigan-Michigan Medicine Cardiovascular Center Ann Arbor, Michigan Todd Koelling, MD - (tkoellin@med.umich.edu)
University of Minnesota Minneapolis, Minnesota
University of Ottawa Heart Institute Ottawa, Ontario David H Birnie, MD - (dbirnie@ottawaheart.ca)
University of Utah Salt Lake City, Utah Line Kemeyou, MD - (line.kemeyou@hsc.utah.edu)
Virginia Commonwealth University Richmond, Virginia Jordana Kron, MD - (jordana.kron@vcuhealth.org)
Yale-New Haven Hospital New Haven, Connecticut Edward Miller, MD - (edward.miller@yale.edu)

An Open-Label Pilot Study of KPL-914 in Recurrent Pericarditis

Wohlford, George, F - wohlfordgf@vcu.edu

Abbate, Antonio
II
14162
HM20014065
drug: Kpl-914
Diseases of Circulatory System (390-459)
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Virginia Commonwealth University Richmond, Virginia Wohlford, George, F - (wohlfordgf@vcu.edu)

Alinity i STAT hsTnI Design Validation Protocol

Ande, Michal - michal.ande@vcuhealth.org

Bachmann, Lorin, M
N/A
14400
HM20014754
Diseases of Circulatory System (390-459)
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Virginia Commonwealth University Richmond, Virginia Ande, Michal - (michal.ande@vcuhealth.org)

FSHD Longitudinal Biomarker Preparatory Study

Diaz, Liz, N - Liz.Diaz@vcuhealth.org

Johnson, Nicholas, E
N/A
14497
HM20015068
Diseases of Nervous System and Sense Organs (320-389)
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Virginia Commonwealth University Richmond, Virginia Diaz, Liz, N - (Liz.Diaz@vcuhealth.org)

Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+ (TEENS+)

Delorme, Janet - janet.delorme@vcuhealth.org

Bean, Melanie, K.
N/A
14519
HM20014304
Any Site, Any Site
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Virginia Commonwealth University Richmond, Virginia Delorme, Janet - (janet.delorme@vcuhealth.org)

Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients with Brain Cancer

Hess, Alison - ahess2@vcu.edu

Chen, Zhi-Jian
I
NCT03423628
HM20012958
Modality: Chemotherapy (nos), Modality: Radiotherapy
Brain and Nervous System
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Virginia Commonwealth University Richmond, Virginia Reidelbach, Erin - (ejmacdonald@vcu.edu)

OKRA STUDY (OKRA)

Ruddley, Joyce, R - joyce.ruddley@vcuhealth.org

Kumar, Dhiren
N/A
NCT03326076
HM20012716
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KOAR
Inclusion Criteria:

• Patient's health care provider adopts and intends to apply the center's AlloSure Routine Testing Schedule as part of the information used to manage the patient.
• Subjects willing to provide written informed consent to participate. KOAR
Exclusion Criteria:
___________________________________________________________ Exclusions for AlloSure? Intended Use Specimens from patients for whom any of the following are true will not be tested:
• Recipients of transplanted organs other than kidney
• Recipients of a transplant from a monozygotic (identical)
• Recipients of a bone marrow transplant
• Recipients who are pregnant
• Recipients who are under the age of 18
• Recipient who are less than 14 days post-transplant
Diagnostic Test: Donor-derived cell-free DNA (AlloSure?), Other: Standard care, Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney), Diagnostic Test: Analytic platform (IBox)
Kidney Transplant Rejection
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AdventHealth Orlando, Florida Ginnette Guzman - (Ginnette.guzman@adventhealth.com) Daniel Robledo - (daniel.robledo@adventhealth.com)
Allegheny General Hospital Pittsburgh, Pennsylvania Svetlana Bondar - (Svetlana.bondar@ahn.org)
Augusta University Augusta, Georgia Torri Blackmon - (TBLACKM2@augusta.edu) Carol Smith - (CSMITH@augusta.edu)
Baylor All Saints Medical Center Fort Worth, Texas
Baylor Scott & White Medical Center Temple, Texas Rohini Bagewadi - (rohini.bagewadi@BSWHealth.org) Melissa Zdorik - (Melissa.Zdroik1@BSWHealth.org)
Beth Israel Deaconess Medical Center Boston, Massachusetts Susan McDermott - (smcderm2@bidmc.harvard.edu)
Brigham and Women's Hospital Boston, Massachusetts
California Pacific Medical Center San Francisco, California
Cedars-Sinai Medical Center Los Angeles, California Nori Ammerman - (Noriko.Ammerman@cshs.org)
Cleveland Clinic - Weston Weston, Florida Sheilla Jerome - (JEROMES@ccf.org) Luz Arazola - (arazol@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio Marina Markovic - (markovm@ccf.org)
Duke University Durham, North Carolina Jose Ramos - (jose.ramos@duke.edu)
East Carolina University/Vidant Medical Center Greenville, North Carolina Josh Yang - (YANGJ15@ECU.EDU)
Erie County Medical Center Buffalo, New York Danielle Wittek - (dwittek@ecmc.edu)
Geisinger Clinic Danville, Pennsylvania Natacha Antunes - (nmantunes@geisinger.edu)
George Washington University Washington D.C., District of Columbia Sarah Andrews - (scandrews@mfa.gwu.edu)
Georgetown University Washington D.C., District of Columbia
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania Robin Neubauer - (Robin.Neubauer@uphs.upenn.edu)
Houston Methodist Hospital Houston, Texas
Indiana University Indianapolis, Indiana Margaret Adebiyi - (madebiyi@iu.edu)
Inova Fairfax Hospital Falls Church, Virginia Percy Julian - (Percy.Julian@inova.org) Sarah Wright - (Sarah.Wright@inova.org)
Integris Baptist Medical Center Oklahoma City, Oklahoma Della Dion - (della.dion@integrisok.com)
Intermountain Medical Center Murray, Utah
Johns Hopkins University Baltimore, Maryland Alyssa Smith - (asmit199@jhmi.edu) Obi Ezennia - (oezenni1@jhmi.edu)
Loma Linda Medical Center Loma Linda, California Andrea Pinto - (APinto@llu.edu)
Loyola University Maywood, Illinois Ted Clevy-Schneller - (Ted.Clevy-schneller@luhs.org) Sana Iqbal - (siqbal5@luc.edu)
Massachusetts General Hospital Boston, Massachusetts Margaret V Thomas - (MVTHOMAS@mgh.harvard.edu)
Medical University of South Carolina Charleston, South Carolina
Methodist Healthcare Foundation Memphis, Tennessee Joseph Youngman - (jyoungman@uthsc.edu) Marisa Wong - (mwong2@uthsc.edu)
Metrolina Nephrology Associates Charlotte, North Carolina Debi Wright - (dwright@metrolinanephrology.com)
Montefiore Medical Center The Bronx, New York Omar Mohammed - (OMOHAMME@montefiore.org)
Ochsner Foundation Hospital New Orleans, Louisiana Angela Smith - (anglsmith@ochsner.org)
Ohio State University Medical Center Columbus, Ohio Margaret Wuebker - (Margaret.Wuebker@osumc.edu)
Rhode Island Hospital Providence, Rhode Island Andrea Viera - (Andrea.Vieira@Lifespan.org) Kylie Freer - (kylie.freer1@lifespan.org)
Rush University Medical Center Chicago, Illinois Sherri Loeb - (Sherri_t_loeb@rush.edu)
SUNY Downstate Medical Center Brooklyn, New York Seema Chittalae - (Seema.Chittalae@downstate.edu)
Sacred Heart Medical Center Eugene, Oregon Lisa Passey - (lisa.passey@providence.org)
Saint Barnabus Medical Center Livingston, New Jersey Ana Merced - (ana.merced@rwjbh.org)
Stanford Health Care San Jose, California Asha Shori - (ashas@stanford.edu) Will Ngo - (wngo008@stanford.edu)
Tampa General Hospital Tampa, Florida
Texas Research Institute Fort Worth, Texas
The Oklahoma Transplant Center at OU Medical Center Oklahoma City, Oklahoma Julie Choate - (Julie.choate@oumedicine.com)
The University of Missouri Columbia, Missouri Mihiri De Silva - (desilvam@health.missouri.edu)
Tulane University Medical Center New Orleans, Louisiana Nicole Lassair - (nlassair@tulane.edu)
UC Davis Medical Center Sacramento, California Katherine Howes - (khowes@ucdavis.edu)
UT Health San Antonio San Antonio, Texas Jillian Woodsworth - (woodworthj@uthscsa.edu)
UT Southwestern Dallas, Texas Whitney Baah - (Witney.Baah@UTSouthwestern.edu) Kazi Moon - (KaziMoon.Moonmoon@UTSouthwestern.edu)
University of Alabama at Birmingham Birmingham, Alabama Tina Parkhill - (tparkhill@uabmc.edu)
University of California San Francisco San Francisco, California Gabriel Garcia - (Gabriel.Garcia@ucsf.edu)
University of California, Los Angeles Los Angeles, California Janette Gadzhyan - (JGadzhyan@mednet.ucla.edu)
University of Chicago Chicago, Illinois Jyotsna Soundararajan - (jsoundararajan@medicine.bsd.uchicago.edu)
University of Colorado Hospital Aurora, Colorado
University of Colorado- Anschutz Medical Campus Aurora, Colorado Lisa Kornfeld - (LISA.KORNFELD@CUANSCHUTZ.EDU)
University of Illinois at Chicago Chicago, Illinois
University of Kansas Medical Center Kansas City, Kansas Erin Delaney - (edelaney@kumc.edu)
University of Kentucky Chandler Hospital Lexington, Kentucky Deepa Valvi - (deepa.valvi@uky.edu)
University of Maryland Baltimore, Maryland Amanda Bartosic - (ABartosic@som.umaryland.edu) Veronica Brown - (VLBrown@som.umaryland.edu)
University of Miami/Jackson Memorial Hospital Miami, Florida
University of Minnesota Medical Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi Delia Owens - (dyowens@umc.edu)
University of Nebraska Medical Center Omaha, Nebraska Katie Ostlund - (katie.ostlund@unmc.edu)
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Michelle Lucas - (mcmeansmm2@upmc.edu)
University of Southern California Los Angeles, California Daisy Rios
University of Utah Salt Lake City, Utah Amber Lamph - (Amber.Lamph@hsc.utah.edu)
University of Washington Medical Center Seattle, Washington Belinda Pan - (bcpan@uw.edu)
Vanderbilt University Medical Center Nashville, Tennessee Malia Reed - (malia.reed@vanderbilt.edu)
Virginia Commonwealth University Richmond, Virginia Joyce Ruddley - (joyce.ruddley@vcuhealth.org)
Wake Forest Baptist Medical Center- Department of General Surgery Winston-Salem, North Carolina Gwen McPherson - (gmcphers@wakehealth.edu)
Washington University St Louis, Missouri
Washington University (Barnes Jewish Hospital) Saint Louis, Missouri Devin Wall - (devinwall@wustl.edu)
Willis-Knighton Physician Network/ John C. McDonald Regional Transplant Center Shreveport, Louisiana Sherry Stephens - (sstephens2@wkhs.com) Amanda Glass - (aglass@wkhs.com)
Yale University New Haven, Connecticut Daksshi Hettiarachichi - (daksshi.hettiarachchi@yale.edu)

Study of INTERCEPT in Regions at Potential Risk for Zika Virus Tranfusion-Transmitted Infections (RedeS)

Fremeau, Jacqueline - jacqueline.barnhardt@vcuhealth.org

Green, Jeffrey, A
III
NCT03037164
HM20013456
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Stage A:
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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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

Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1

Howell, Jodie - jodie.howell@vcuhealth.org

Johnson, Nicholas, E
N/A
14536
HM20014419
Diseases of Musculoskeletal System and Connective Tissue (710-739), Diseases of Musculoskeletal System and Connective Tissue (710-739), Diseases of Musculoskeletal System and Connective Tissue (710-739)
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Virginia Commonwealth University Richmond, Virginia Holmberg, Brittney, A - (Brittney.Holmberg@vcuhealth.org)

Use of Simultaneous Multi-Slice Imaging for Pediatric Brain MRI Compared with Standard TSE Sequences

Lessard, Margaret - margaret.lessard@vcuhealth.org

Vorona, Gregory
N/A
14702
HM20014210
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Virginia Commonwealth University Richmond, Virginia Lessard, Margaret - (margaret.lessard@vcuhealth.org)

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (TRANSCEND )

BMS Study Connect Contact Center www.BMSStudyConnect.com - Clinical.Trials@bms.com

McCarty, John, M.
PHASE1
NCT03331198
HM20016147
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Inclusion Criteria:
* Diagnosis of:
• CLL with an indication for treatment based on the Investigator's opinion and measurable disease, or
• SLL (lymphadenopathy and/or splenomegaly and \< 5×10\^9 CD19+ CD5+ clonal B lymphocytes/L \[\< 5000/µL\] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL) * Subjects (other than those in the ibrutinib + JCAR017 combination therapy and DEME cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy. * Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:
• Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.
• Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.
• DEME cohort ONLY: Subjects with relapsed or refractory CLL or SLL, irrespective of cytogenetic risk features, must have received at least 2 lines of prior therapy including a BTKi and a BCL2i. * Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:
• be receiving ibrutinib and progressing at the time of study enrollment
• be receiving ibrutinib for at least 6 months with a response less than complete response/remission (CR) and have high-risk features as defined in inclusion criterion 5a
• have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib
• have previously received ibrutinib and have no contraindications to restarting ibrutinib * Eastern Cooperative Oncology Group performance status of ≤ 1 * Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy * Adequate organ function, defined as:
• Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance \> 30 mL/min
• Alanine aminotransferase ≤ 5 × ULN and total bilirubin \< 2.0 mg/dL (or \< 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)
• Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air
• Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility * Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure. * If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy. * Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax * Subjects in venetoclax + JCAR017 combination cohort must:
• have failed at least 1 prior line of therapy, including failed BTKi therapy or have been deemed ineligible to receive BTKi
• be venetoclax naive (required for dose expansion) or
• if prior venetoclax (only for dose escalation)
• have no contraindictions to re-initiation of venetoclax based on prior intolerance and have had at least 6 months elapsed since the last dose of venetoclax, if either, best response was stable disease, or subject experienced disease progression on venetoclax, or within 6 months of venetoclax discontinuation * subjects in the venetoclax + JCAR017 combination must have hemoglobin \>=9 g/dL, absolute neutrophil count \>=500mm3 and platelets\>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow * must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes ≥1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry
Exclusion Criteria:
* Subjects with known active central nervous system (CNS) involvement by malignancy. Those with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging. * History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.) * Subjects with Richter's transformation * Prior treatment with any gene therapy product * Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection * Systemic fungal, bacterial, viral, or other infection that is not controlled * Presence of acute or extensive chronic graft versus host disease (GVHD) * History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease * History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or psychosis * Pregnant or nursing (lactating) women * Use of any of the following medications or treatments within the noted time prior to leukapheresis:
• Alemtuzumab within 6 months prior to leukapheresis
• Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis
• Cladribine within 3 months prior to leukapheresis
• Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis
• Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis
• Fludarabine within 4 weeks prior to leukapheresis
• GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-α \[TNFα\], anti-interleukin-6 \[IL-6\], or anti-interleukin-6 receptor \[IL 6R\]) within 4 weeks prior to leukapheresis
• Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis
• Therapeutic doses of corticosteroids (defined as \> 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis
• Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis
• Venetoclax within 4 days prior to leukapheresis
• Idelalisib or duvelisib within 2 days prior to leukapheresis
• Lenalidomide or covalent and non-covalent BTKi within 1 day prior to leukapheresis
• Experimental agents, including off-label use of approved drugs (with the exception of acalabrutinib which may be continued up to the day before leukapheresis), within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis * Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol * Progressive vascular tumor invasion, thrombosis, or embolism * Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation * Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis. * Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation * For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued
BIOLOGICAL: JCAR017 (lisocabtagene maraleucel), BIOLOGICAL: JCAR017 (lisocabtagene maraleucel) + ibrutinib, BIOLOGICAL: JCAR017 (lisocabtagene maraleucel) + venetoclax
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Small Lymphocytic
TRANSCEND_CLL_004
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Study Locations

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Location Contacts
Astera Cancer Care East Brunswick, New Jersey
Atlantic Health System / Morristown Medical Center Morristown, New Jersey
Banner MD Anderson Cancer Center Gilbert, Arizona Brenda Noggy - (brenda.noggy@bannerhealth.com)
Banner MD Anderson Cancer Center Gilbert, Arizona
Barbara Ann Karmanos Cancer Institute Detroit, Michigan Joo En Kim, MPH - (kimjo@karmanos.org)
Baylor University Medical Center Dallas, Texas
Beth Israel Deaconess Medical Center Boston, Massachusetts Emma Logan, RN - (eklogan@bidmc.harvard.edu) Pavania Elavalakanar - (pelavala@bidmc.harvard.edu)
City of Hope Duarte, California Hormoz Mirshkarlo, MD - (hmirshkarlo@coh.org)
City of Hope Duarte, California
Colorado Blood Cancer Institute Denver, Colorado
Columbia University Medical Center New York, New York
Duke University Medical Center Durham, North Carolina
Duke University Medical Center Durham, North Carolina Rachel Stowe - (rachel.stowe@duke.edu) Danielle M Brander, MD - (danielle.brander@duke.edu)
Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT) Indianapolis, Indiana
Fred Hutchinson Cancer Research Center Seattle, Washington SCCA Immunotherapy Trials Intake - (immunotherapy@seattlecca.org)
Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin
Georgetown University Medical Center Washington D.C., District of Columbia Pari Ramzi - (ramzip1@georgetown.edu)
Hackensack University Medical Center Hackensack, New Jersey Kara Yannotti, RNC - (Kara.Yannotti@Hackensackmeridian.org)
Huntsman Cancer Institute Salt Lake City, Utah Kolleen Hicks, BS - (Kolleen.Hicks@hci.utah.edu)
John Theurer Cancer Center Hackensack, New Jersey
Local Institution - 0001 Lenexa, Kansas
Local Institution - 0005 Leeds,
Local Institution - 0010 San Francisco, California
Local Institution - 0015 Boston, Massachusetts
Local Institution - 0018 Seattle, Washington
Local Institution - 0019 Atlanta, Georgia
Local Institution - 0026 New York, New York
Local Institution - 0027 New Orleans, Louisiana
Local Institution - 0028 Salt Lake City, Utah
Local Institution - 0029 Pittsburgh, Pennsylvania
Local Institution - 0035 New York, New York
Local Institution - 0059 Los Angeles, California
Local Institution - 0062 Detroit, Michigan
Local Institution - 0077 New Brunswick, New Jersey
Local Institution - 0079 Dallas, Texas
Local Institution - 0083 Dallas, Texas
Local Institution - 0085 Washington D.C., District of Columbia
Local Institution - 0087 Richmond, Virginia
Local Institution - 0098 Porto,
Local Institution - 0104 Atlanta, Georgia
Local Institution - 0107 Wichita, Kansas
Local Institution - 0109 Chile, Santiago Metropolitan
Local Institution - 0110 Newark, Delaware
Local Institution - 0112 Toronto, Ontario
Local Institution - 0113 Charlottesville, Virginia
Massachusetts General Hospital Boston, Massachusetts Jacob D Soumerai, MD - (jsoumerai@mgh.harvard.edu)
Mayo Clinic Rochester, Minnesota Mohamed Kharfan-Dabaja, MD - (kharfandabaja.mohamed@mayo.edu) Teresa Banda - (teresa.banda@bswhealth.org)
Mayo Clinic Rochester, Minnesota Gabrielle Bouska - (bouska.gabrielle@mayo.edu)
Mayo Clinic Rochester, Minnesota
Mayo Clinic - Jacksonville Jacksonville, Florida
Medical College of Wisconsin Milwaukee, Wisconsin Nirav Shah, MD - (nishah@mcw.edu)
Northwestern Memorial Hospital Chicago, Illinois
Northwestern University Chicago, Illinois Study Coordinator - (cancertrials@northwestern.edu) Arezou Ireta - (a-ireta@northwestern.edu)
Norton Healthcare - Norton Cancer Institute Louisville, Kentucky
Princess Margaret Cancer Centre Toronto, Ontario
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey Oona Harrigan - (oh77@cinj.rutgers.edu) Roger Strair, MD, PhD - (strairrk@cinj.rutgers.edu)
Stony Brook University Stony Brook, New York
The Blood and Marrow Transplant Group of Georgia (BMTGA) Atlanta, Georgia Scott R Solomon, MD - (ssolomon@bmtga.com) Stacey Brown - (Stacey.brown@northside.com)
The Ohio State University Comprehensive Cancer Center Columbus, Ohio
The University of Texas - MD Anderson Cancer Center Houston, Texas
The University of Texas MD Anderson Cancer Center Houston, Texas William G Wierda, MD, PhD - (wwierda@mdanderson.org)
Thomas Jefferson University Philadelphia, Pennsylvania Allison Scott - (allison.scott@jefferson.edu)
Thomas Jefferson University - Clinical Research Institute Philadelphia, Pennsylvania
UC San Diego Moores Cancer Center La Jolla, California Krisma C Montalvo - (kcmontalvo@ucsd.edu) Kimberly Aguilar - (k1aguilar@ucsd.edu)
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania - (fukaslj@upmc.edu)
University Hospitals Cleveland Medical Center Cleveland, Ohio
University Hospitals Seidman Cancer Center (Case Western) Cleveland, Ohio Paolo Caimi, MD - (Paolo.Caimi@UHhospitals.org) Yeritza Hernandez-Collazo, MS - (Yeritza.Hernandez-Collazo@UHhospitals.org)
University of Alabama Birmingham Birmingham, Alabama
University of Alabama at Birmingham Birmingham, Alabama Tiffany Hill - (tiffanydhill@uabmc.edu) Danielle Mussey - (dmussey@uabmc.edu)
University of California San Diego Moores Cancer Center La Jolla, California
University of California, Los Angeles Los Angeles, California Joy Valadez - (jvaladez@mednet.ucla.edu) Anna Crosetti - (acrosetti@mednet.ucla.edu)
University of California, San Francisco San Francisco, California Andrew Chon - (andrew.chon@ucsf.edu)
University of Chicago Medical Center Chicago, Illinois Sadi Dixon, RN - (sdixon2@medicine.bsd.uchicago.edu) Elaine Hoekstra - (ehoekstra1@medicine.bsd.uchicago.edu)
University of Chicago Medical Center Chicago, Illinois
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan
University of Nebraska Medical Center Omaha, Nebraska Gail A Paulsen - (gpaulsen@unmc.edu) Lindsay Hicks - (lindsay.hick@unmc.edu)
University of Nebraska Medical Center Omaha, Nebraska
University of Oklahoma Health Sciences Center (Stephenson Cancer Center) Oklahoma City, Oklahoma Adam Asch, MD - (adam-asch@ouhsc.edu)
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, MD - (stephen.schuster@uphs.upenn.edu)
University of Texas Southwestern Medical Center Dallas, Texas Courtney Saltarski - (courtney.saltarski@utsouthwestern.edu) Farrukh Awan, MD - (farrukh.awan@utsouthwestern.edu)
Virginia Commonwealth University Richmond, Virginia
Weill Cornell Medical College New York, New York June Greenburg - (jdg2002@med.cornell.edu) Koen Van Besien - (kov9001@med.cornell.edu)