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6 Study Matches
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)
Katherine Wu, MD - kwu@jhmi.edu
NCT00733590
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Inclusion Criteria:
* History of acute MI at least 4 weeks old
* Non-ischemic LV dysfunction for at least 9 months
* Who have an ejection fraction (EF) \< or = to 35%
* Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment.
* Who have primary prevention implants.
Exclusion Criteria:
* ICD generator replacement for secondary prevention
* Inability or unwillingness to provide valid informed consent
* New York Heart Association Class IV heart failure
* Patients with pre-existing Class 1 indications for pacemaker therapy. Heart Failure, Congestive, Death, Sudden, Cardiac, Arrhythmia, Cardiomyopathies
defibrillator, implanted, genomics, electrocardiography, electrophysiological study, proteomics
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Study Locations
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| Location | Contacts |
|---|---|
| Johns Hopkins University School Of Medicine Baltimore, Maryland | Katherine Wu, MD - (kwu@jhmi.edu) |
| University of Maryland Medical Center Baltimore, Maryland | Stephen R Shorofsky, MD, PhD - (Sshorofs@medicine.umaryland.edu) |
| Virginia Commonwealth University School of Medicine Richmond, Virginia | Kenneth Ellenbogen, MD - (kellenbogen@pol.net) |
| Washington Hospital Center Washington D.C., District of Columbia | Zayd Eldadah, MD, PhD - (Zayd.Eldadah@Medstar.Net) |
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Boomer, Laura, A
NCT05235165
HM20024392
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Inclusion Criteria:
* Patients must be \< 50 years at the time of enrollment.
* Patients must have =\< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \>= 3 mm and all of which must be =\< 3 cm size.
* Note: Patient must have eligibility confirmed by rapid central imaging review.
* Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
* Patients must have a histological diagnosis of osteosarcoma.
* Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
* Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
* Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
* Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
Exclusion Criteria:
* Patients with unresectable primary tumor.
* Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
* Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
* Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
* Patients with evidence of extrapulmonary metastatic disease.
* Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
* 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. PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, OTHER: Questionnaire Administration, PROCEDURE: Thoracoscopy, PROCEDURE: Thoracotomy
Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
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Study Locations
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| Location | Contacts |
|---|---|
| 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) |
| Ann M Wierman MD LTD Las Vegas, Nevada | |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Arnold Palmer Hospital for Children Orlando, Florida | Site Public Contact - (Jennifer.spinelli@orlandohealth.com) |
| BI-LO Charities Children's Cancer Center Greenville, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| Banner Children's at Desert Mesa, Arizona | |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Beacon Kalamazoo Kalamazoo, Michigan | |
| Beacon Kalamazoo Cancer Center Kalamazoo, Michigan | |
| Blank Children's Hospital Des Moines, Iowa | Site Public Contact - (samantha.mallory@unitypoint.org) |
| Bronson Battle Creek Battle Creek, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Bronson Methodist Hospital Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| C S Mott Children's Hospital Ann Arbor, Michigan | |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan | |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | |
| Carilion Children's Roanoke, Virginia | Site Public Contact - (wpmccarty@carilionclinic.org) |
| Carson Tahoe Regional Medical Center Carson City, Nevada | Site Public Contact - (research@sncrf.org) |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| 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 Colorado Aurora, Colorado | Site Public Contact - (josh.b.gordon@nsmtp.kp.org) |
| Children's Hospital Los Angeles Los Angeles, California | |
| Children's Hospital Medical Center Of Akron Akron, Ohio | |
| Children's Hospital New Orleans New Orleans, Louisiana | |
| Children's Hospital and Medical Center of Omaha Omaha, Nebraska | |
| Children's Hospital at Montefiore The Bronx, New York | Site Public Contact - (aaraiza@montefiore.org) |
| Children's Hospital of Alabama Birmingham, Alabama | Site Public Contact - (oncologyresearch@peds.uab.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Site Public Contact - (helpdesk@childrensoncologygroup.org) |
| Children's Hospital of Orange County Orange, California | Site Public Contact - (oncresearch@choc.org) |
| Children's Hospital of 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 - (COGResearchGroup@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) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Connecticut Children's Medical Center Hartford, Connecticut | |
| Cook Children's Medical Center Fort Worth, Texas | Site Public Contact - (CookChildrensResearch@cookchildrens.org) |
| Corewell Health Children's Royal Oak, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Reed City Hospital Reed City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Dayton Children's Hospital Dayton, Ohio | |
| Dell Children's Medical Center of Central Texas Austin, Texas | Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org) |
| Driscoll Children's Hospital Corpus Christi, Texas | Site Public Contact - (Crystal.DeLosSantos@dchstx.org) |
| Duke University Medical Center Durham, North Carolina | |
| East Carolina University Greenville, North Carolina | Site Public Contact - (eubankss@ecu.edu) |
| East Tennessee Childrens Hospital Knoxville, Tennessee | |
| Eastern Maine Medical Center Bangor, Maine | |
| El Paso Children's Hospital El Paso, Texas | Site Public Contact - (ranjan.bista@ttuhsc.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (cancerresearch@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 | |
| Hope Cancer Care of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada | Site Public Contact - (research@sncrf.org) |
| IWK Health Centre Halifax, Nova Scotia | Site Public Contact - (Research@iwk.nshealth.ca) |
| Inova Fairfax Hospital Falls Church, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| 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 Los Angeles Medical Center Los Angeles, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Anaheim Anaheim, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Bellflower Bellflower, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Fontana Fontana, California | Site Public Contact - (clinical.trials@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Diego Zion San Diego, California | Site Public Contact - (clinical.trials@kp.org) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| King Faisal Specialist Hospital and Research Centre Riyadh, | |
| Kingman Regional Medical Center Kingman, Arizona | Site Public Contact - (research@sncrf.org) |
| Las Vegas Cancer Center-Henderson Henderson, Nevada | |
| Las Vegas Cancer Center-Medical Center Las Vegas, Nevada | |
| Las Vegas Urology - Cathedral Rock Las Vegas, Nevada | |
| Las Vegas Urology - Green Valley Henderson, Nevada | |
| Las Vegas Urology - Pebble Henderson, Nevada | |
| Las Vegas Urology - Pecos Las Vegas, Nevada | |
| Las Vegas Urology - Smoke Ranch Las Vegas, Nevada | |
| Las Vegas Urology - Sunset Las Vegas, Nevada | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York | Site Public Contact - (CancerTrials@nyulangone.org) |
| Legacy Emanuel Children's Hospital Portland, Oregon | |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Loma Linda University Medical Center Loma Linda, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lucile Packard Children's Hospital Stanford University Palo Alto, California | Site Public Contact - (ccto-office@stanford.edu) |
| Lurie Children's Hospital-Chicago Chicago, Illinois | |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Children's Cancer Program Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | 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 | |
| Mayo Clinic in Rochester Rochester, Minnesota | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Charleston, South Carolina | Site Public Contact - (hcc-clinical-trials@musc.edu) |
| 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) |
| 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) |
| Montefiore Medical Center - Moses Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Montefiore Medical Center-Weiler Hospital The Bronx, New York | Site Public Contact - (eskwak@montefiore.org) |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York | Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu) |
| Nationwide Children's Hospital Columbus, Ohio | Site Public Contact - (Melinda.Triplet@nationwidechildrens.org) |
| Nemours Children's Clinic-Jacksonville Jacksonville, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| Nemours Children's Hospital Orlando, Florida | Site Public Contact - (Allison.bruce@nemours.org) |
| New York Medical College Valhalla, New York | |
| Nicklaus Children's Hospital Miami, Florida | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington | Site Public Contact - (Memorial-ClinicalTrials@yvmh.org) |
| Northern Nevada Radiation Oncology Reno, Nevada | |
| 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) |
| OSF Children's Hospital of Illinois Peoria, Illinois | Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org) |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| Oncology Las Vegas - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Oncology Las Vegas - Tenaya Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at Fort Apache Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| OptumCare Cancer Care at MountainView Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Overlake Medical Center Bellevue, Washington | |
| PCR Oncology Arroyo Grande, California | Site Public Contact - (research@sncrf.org) |
| Penn State Children's Hospital Hershey, Pennsylvania | |
| Perth Children's Hospital Perth, Western Australia | |
| Phoenix Childrens Hospital Phoenix, Arizona | |
| Presbyterian Hospital Albuquerque, New Mexico | Site Public Contact - (wburman@phs.org) |
| Primary Children's Hospital Salt Lake City, Utah | |
| Prisma Health Richland Hospital Columbia, South Carolina | Site Public Contact - (Kim.Williams3@prismahealth.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Alaska Medical Center Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington | Site Public Contact - (HopeBeginsHere@providence.org) |
| Radiation Oncology Associates Reno, Nevada | |
| Radiation Oncology Centers of Nevada Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Rady Children's Hospital - San Diego San Diego, California | |
| Rainbow Babies and Childrens Hospital Cleveland, Ohio | |
| Renown Regional Medical Center Reno, Nevada | Site Public Contact - (Renown-CRD@renown.org) |
| Rhode Island Hospital Providence, Rhode Island | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado | Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com) |
| Royal Children's Hospital Parkville, Victoria | |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| 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 Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Regional Medical Center Reno, Nevada | Site Public Contact - (research@sncrf.org) |
| Saint Peter's University Hospital New Brunswick, New Jersey | Site Public Contact - (kcovert@saintpetersuh.com) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Seattle Children's Hospital Seattle, Washington | |
| Sinai Hospital of Baltimore Baltimore, Maryland | |
| Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
| 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) |
| 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 | |
| Trinity Health Grand Rapids Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Trinity Health Muskegon Hospital Muskegon, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| UCSF Medical Center-Mission Bay San Francisco, California | Site Public Contact - (cancertrials@ucsf.edu) |
| UF Health Cancer Institute - Gainesville Gainesville, Florida | |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT MD Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Medical Center of Southern Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| University of 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 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 Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Children's Hospital Columbia, Missouri | Site Public Contact - (snwq62@health.missouri.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| 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 | |
| University of Virginia Cancer Center Charlottesville, Virginia | Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| Urology Specialists of Nevada - Central Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Green Valley Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Urology Specialists of Nevada - Southwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Valley Children's Hospital Madera, California | Site Public Contact - (Research@valleychildrens.org) |
| Valley Medical Center Renton, Washington | Site Public Contact - (research@valleymed.org) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Michigan Cancer Center Kalamazoo, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Westchester Medical Center Valhalla, New York | |
| Yale University New Haven, Connecticut | Site Public Contact - (canceranswers@yale.edu) |
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma (STRASS2)
EORTC HQ - 1809@eortc.org
NCT04031677
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• STRASS 2
Inclusion Criteria:
* Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.
* LMS:
* Any grade LMS can be included
* Minimum size of LMS tumor should be 5 cm
* LPS:
* Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while proof of MDM2 amplification is highly recommended.
* All grade 3 DDLPS can be included.
* DDLPS with confirmed grade 2 on biopsy can be included when:
* The grade 2 DDLPS has an FNCLCC score=5 (Fédération Nationale des Centres de Lutte Contre Le Cancer), and clear necrosis on imaging (whether or not present on the biopsy).
* The tumors carry a high risk gene profile as determined by the Complexity INdex in SARComas (CINSARC-high)
* Unifocal tumour
* Resectable tumour: resectability is based on pre-operative imaging (CT-abdomen, potentially also with MRI) and has to be defined by the local treating sarcoma team. A patient is not considered resectable when the expectation is that only an R2 resection is feasible.
* Criteria for non-resectability are:
* Involvement of the superior mesenteric artery, aorta, coeliac trunk and/or portal vein
* Involvement of bone
* Growth into the spinal canal
* Progression of retro-hepatic inferior vena cava leiomyosarcoma towards the right atrium
* Infiltration of multiple major organs like liver, pancreas and or major vessels
* Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by imaging. CT thorax abdomen pelvis with IV contrast is the preferred imaging modality. In case of any contra-indications (medical or regulatory), it is allowed to perform a non-contrast CT thorax + MRI abdomen \& pelvis
* Collection of tumour tissue for central pathology review is mandatory.
* For patients with LMS: if there is not enough tissue for assessing the grading, this is acceptable.
* If tumour tissue is not available for the central pathology review, patient will not be eligible.
* If the biopsy was not done or the FFPE of the biopsy not available but at least 10 unstained slides or one pathological block are available for the central review, that will be considered as acceptable.
* For the biopsy if fine needle aspiration (FNA) is performed instead of core needle biopsy (CNB) recommended by the standard guidelines, please contact the EORTC medical monitors for further evaluation.
* Collection of tumour tissue and blood samples for translational research is mandatory.
* In case there is not enough tissue for TR, a new biopsy is not required and if the patient fulfils all other eligibility criteria, he/she will be eligible.
* If the blood samples are not collected, patient will not be eligible.
* If the patient refuses the collection of biomaterial for TR, patient will not be eligible even if he/she fulfils all other eligibility criteria
* ≥ 18 years old (no upper age limit)
* WHO performance status ≤ 2
* Adequate haematological and organ function
* American Society of Anaesthesiologist (ASA) score \< 3
* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.
Note: a woman is considered of childbearing potential, i.e., fertile, if she is following menarche. She remains of childbearing potential until she becomes post-menopausal or permanently sterile.Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 consecutive months without menses, a single FSH measurement is insufficient.
* WOCBP in both arms should use highly effective birth control measures, during the study treatment period and for at least 6 months after the last dose of chemotherapy or date of surgery (except for women receiving chemotherapy with ifosfamide who should continue contraception until 1 year after last day of treatment). A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
* For men in the experimental arm: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
* Female subjects who are breast feeding should discontinue nursing prior to the first day of study treatment and until 6months after the last study treatment.
* Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion criteria:
* Sarcoma originating from bone structure, abdominal or gynecological viscera
* Extension through the sciatic notch or across the diaphragm
* Metastatic disease
* Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour
* Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients
* Congestive heart failure
* Angina pectoris
* Myocardial infarction within 1 year before randomization
* Uncontrolled arterial hypertension defined as blood pressure ≥ 150/100 mm Hg despite optimal medical therapy.
Note: in case of high blood pressure: 1) initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; 2) blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP / DBP values from each blood pressure assessment must be ≤ 150/90mmHg in order for a patient to be eligible for the study.
* Uncontrolled cardiac arrhythmia
* Previous treatment with maximum cumulative doses (450mg/m² Doxorubicin or equivalent 900mg/m² Epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
* Active and uncontrolled infections
* Vaccination with live vaccines within 30 days prior to study entry
* Inflammation of the urinary bladder (interstitial cystitis) and/or obstructions of the urine flow.
* Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason ≤ 6prostate cancer.
* Uncontrolled severe illness, infection, medical condition (including uncontrolled diabetes), other than the primary LPS or LMS of the retroperitoneum.
* Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control method.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
* Known contraindication to imaging tracer and to MRI
• Selection criteria for STREXIT 2 * Patients with histologically proven primary resectable localized high-risk DDLPS or LMS of retroperitoneal space or infra-peritoneal spaces of pelvis (as described in the inclusion criteria of STRASS 2) and amenable to receive chemotherapy but for whom the list of eligibility criteria for the study is too restrictive (tumour grading not available, inadequate organ function, concomitant diseases) * Patients who meet all eligibility criteria of STRASS 2 but do not consent to randomization or are not enrolled for any other reason. * Patients enrolled in a Registry collecting data on primary RPS patients in the centres participating in STRASS 2 (e.g., RESAR) and who satisfy the above criteria.
• Selection criteria for preferences for neoadjuvant chemotherapy in STRASS 2 substudy All patients recruited to STRASS 2 in participating centres (Australia +/- international sites) that are able to read, comprehend and write in English at a sufficient level to complete study materials.
PROCEDURE: Surgery, DRUG: Preoperative chemotherapy
Retroperitoneal Sarcoma, Liposarcoma, Leiomyosarcoma
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Show 176 locations
Study Locations
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| Location | Contacts |
|---|---|
| Aarhus University Hospitals - Aarhus University Hospital-Skejby Aarhus, | |
| Aichi Cancer Center Chikusa-ku, Nagoya | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Allegheny Valley Hospital Natrona Heights, Pennsylvania | |
| BCCA - Vancouver Cancer Centre Vancouver, British Columbia | |
| Bank Of Cyprus Oncology Centre Stróvolos, | |
| Cancer Institute Hospital of Jfcr Koto-ku, Tokyo | |
| Carilion Roanoke Memorial Hospital Roanoke, Virginia | |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Centre Leon Berard Lyon, Auvergne-Rhône-Alpes | |
| Centro di Riferimento Oncologico Aviano, | |
| Chris O'Brian Life House - Chris O'Brien Lifehouse Camperdown, | |
| City of Hope Comprehensive Cancer Center Duarte, California | |
| Clatterbridge cancer center Metropolitan Borough of Wirral, | |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| Dana-Farber/Harvard Cancer Center Boston, Massachusetts | |
| Dartmouth Hitchcock Med Ctr/Dartmouth Cancer Ctr Lebanon, New Hampshire | |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duke University Medical Center Durham, North Carolina | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| FHCC South Lake Union Seattle, Washington | |
| Forbes Hospital Monroeville, Pennsylvania | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Froedtert and MCW Moorland Reserve Health Center New Berlin, Wisconsin | |
| HMH-Hackensack University Medical Center Hackensack, New Jersey | |
| Herlev Hospital - University Copenhagen Herlev, Copenhagen | |
| Hopital Maisonneuve Rosemont Montreal, Quebec | |
| Hopitaux Universitaires de Strasbourg - Hautepierre Strasbourg, | |
| Hospital De La Santa Creu I Sant Pau Barcelona, | |
| Hospital General Universitario Gregorio Marañon Madrid, | |
| Hospital Universitario Fundacion Jimenez Diaz Madrid, | |
| Hospital Universitario San Carlos Madrid, | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | |
| IRCCS - Fondazione Piemonte Inst di Candiolo Candiolo, | |
| IRCCS - Istituto Nazionale dei Tumori Milan, | |
| IRCCS - Istituto Oncologico Veneto Padova, | |
| IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" Meldola, | |
| Indiana Univ/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | |
| Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol Barcelona, | |
| Institut Curie- Hopital de Paris Paris, | |
| Institut Gustave Roussy Villejuif, | |
| Institut du Cancer de Montpellier Montpellier, | |
| Istituto Clinico Humanitas Rozzano (MI), Lombardy | |
| Istituto Europeo Di Oncologia Milan, | |
| James Graham Brown Ca Ctr at Univ of Louisville Louisville, Kentucky | |
| Jefferson Hospital Jefferson Hills, Pennsylvania | |
| Jersey Shore University Medical Center Neptune City, New Jersey | |
| John Theurer Cancer Center at From Road Paramus, New Jersey | |
| Johns Hopkins Univ/Sidney Kimmel Cancer Center Baltimore, Maryland | |
| Kanagawa Cancer Center Yokohama, | |
| Kyushu University Hospital Fukuoka, | |
| LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana | |
| Laura and Issac Perlmutter Ca Ctr at NYU Langone New York, New York | |
| Leeds Teaching Hospitals NHS Trust - St. James's University Hospital Leeds, | |
| Leiden University Medical Centre Leiden, | |
| London Regional Cancer Center London, Ontario | |
| Long Island Jewish Medical Center New Hyde Park, New York | |
| M D Anderson Cancer Center Houston, Texas | |
| Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology Warsaw, | |
| Marshfield Med Ctr-River Region at Stevens Point Stevens Point, Wisconsin | |
| Marshfield Medical Center Marshfield, Wisconsin | |
| Marshfield Medical Center Marshfield, Wisconsin | |
| Marshfield Medical Center Marshfield, Wisconsin | |
| Marshfield Medical Center Marshfield, Wisconsin | |
| Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin | |
| Masaryk Memorial Cancer Institute Brno, | |
| Mayo Clinic Rochester, Minnesota | |
| Mayo Clinic Hospital in Arizona Phoenix, Arizona | |
| Mayo Clinic in Florida Jacksonville, Florida | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Midwestern Regional Medical Center Zion, Illinois | |
| Moffitt Cancer Center Tampa, Florida | |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | |
| Moffitt Cancer Center-International Plaza Tampa, Florida | |
| Montefiore Medical Center - Moses Campus The Bronx, New York | |
| Montefiore Medical Center-Einstein Campus The Bronx, New York | |
| Mount Sinai Hospital New York, New York | |
| NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital Glasgow, | |
| NYU Langone Hospital - Long Island Mineola, New York | |
| Nagoya University Hospital Aichi, Nagoya, | |
| National Cancer Center Hospital Chūōku, | |
| National Cancer Institute Bratislava, | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | |
| Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care Newcastle, | |
| Niigata University Medical and Dental Hospital Niigata, Niigata, | |
| North Shore University Hospital Manhasset, New York | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwestern University Chicago, Illinois | |
| Nottingham University Hospitals NHS Trust - City Hospital Nottingham, | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | |
| Okayama University Hospital Okayama, | |
| Oregon Health and Science University Portland, Oregon | |
| Osaka International Cancer Institute Osaka, | |
| Our Lady of the Lake Hospital Baton Rouge, Louisiana | |
| Our Lady of the Lake Physician Group Baton Rouge, Louisiana | |
| Oxford University Hospitals NHS Trust - Churchill Hospital Oxford, | |
| Pennsylvania Hospital Philadelphia, Pennsylvania | |
| Peter Maccallum Cancer Institute Melbourne, Victoria | |
| Policlinico Universitario Campus Bio-Medico- Oncology Center Roma, | |
| Princess Alexandra Hospital - University Of Queensland Woolloongabba, Queensland | |
| Radboudumc - Radboud University Medical Center Nijmegen Nijmegen, | |
| Renown Regional Medical Center Reno, Nevada | |
| Rhode Island Hospital Providence, Rhode Island | |
| Roswell Park Cancer Institute Buffalo, New York | |
| Rush University Medical Center Chicago, Illinois | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Saint Vincent Hospital Erie, Pennsylvania | |
| Saitama Medical Center, Jichi Medical University Saitama, | |
| Sanford Bismarck Medical Center Bismarck, North Dakota | |
| Sanford Broadway Medical Center Fargo, North Dakota | |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | |
| Siteman Cancer Center-South Country St Louis, Missouri | |
| Siteman Cancer Center-West County Creve Coeur, Missouri | |
| Smilow Cancer Hospital Care Center - Guiford Guilford, Connecticut | |
| Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut | |
| Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island | |
| Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut | |
| Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut | |
| Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut | |
| Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut | |
| Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut | |
| Smilow Cancer Hospital Care Ctr at Saint Francis Hartford, Connecticut | |
| Smilow Cancer Hospital-Derby Care Center Derby, Connecticut | |
| Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut | |
| Stony Brook University Medical Center Stony Brook, New York | |
| The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis Amsterdam, | |
| The Ottawa Hospital - General Campus Ottawa, Ontario | |
| The Research Institute of the McGill University Health Centre Montreal, Quebec | |
| The Royal Marsden Hospital London, | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | |
| Tohoku University Hospital Sendai, Miyagi | |
| UC Irvine Health/Chao Family Comprehensive Ca Ctr Orange, California | |
| UC San Diego Moores Cancer Center La Jolla, California | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCI Health-Chao Family Comp CC and Ambulatory Care Irvine, California | |
| UPMC Hillman Cancer Center Pittsburgh, Pennsylvania | |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | |
| Univ of Florida Health Science Ctr - Gainesville Gainesville, Florida | |
| UniversitaetsMedizin Mannheim Mannheim, | |
| Universitaetsklinikum Carl Gustav Carus Dresden, | |
| Universitaetsmedizin Goettingen - Georg-August Universitaet Goettigen, Lower Saxony | |
| University Hospital Motol Prague, | |
| University Hospitals Birmingham - Queen Elisabeth Medical Centre Birmingham, | |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | |
| University of Illinois at Chicago MBCCOP Chicago, Illinois | |
| University of Kansas Cancer Center Kansas City, Kansas | |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | |
| University of Kansas Hospital-Westwood Cancer Ctr Westwood, Kansas | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Tennessee - Knoxville Knoxville, Tennessee | |
| University of Vermont Medical Center Burlington, Vermont | |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| UofL Health Medical Center Northeast Louisville, Kentucky | |
| VCU Community Memorial Health Center South Hill, Virginia | |
| VCU Massey Cancer Center at Hanover Medical Park Mechanicsville, Virginia | |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Vermont Regional Cancer Center Burlington, Vermont | |
| Virginia Commonwealth Univ/Massey Cancer Center Richmond, Virginia | |
| Washington University School of Medicine - Siteman Cancer Center St Louis, Missouri | |
| West Penn Hospital Pittsburgh, Pennsylvania | |
| Wexford Health and Wellness Pavilion Wexford, Pennsylvania | |
| Yale University New Haven, Connecticut | |
| Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut | |
| Yokohama City University Hospital Kanagawa, Yokohama, |
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator (CARVTOP-ICD)
Mehmet Aktas, M.D. - Mehmet_Aktas@URMC.Rochester.edu
NCT06964464
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Inclusion Criteria:
* Age ≥ 18 years
* ICD implanted for primary prevention for HFrEF (either ICM or NICM) with remote monitoring capability
* Current treatment with metoprolol succinate and willing to switch to carvedilol
* LVEF \<50% during the past 12 months prior to consent
Exclusion Criteria:
* Unwilling or unable to follow the protocol
* Treatment with any other ßB than metoprolol succinate or no ßB treatment
* Known prior intolerance or contraindication to carvedilol
* Systolic blood pressure \<100 mmHg
* Enrollment in another clinical trial
* Inability or unwilling to consent DRUG: Metoprolol Succinate, DRUG: Carvedilol
Heart Failure With Reduced Ejection Fraction (HFrEF), Sudden Cardiac Death, Ventricular Arrhythmia, Implantable Cardioverter Defibrillator (ICD), Beta-blocker Therapy, Cardiomyopathy
arrhythmia, heart failure, ICD, implantable cardioverter defibrillator, ICD shock, carvedilol, metoprolol succinate, beta-blocker
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Show 13 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Redmond Rome, Georgia | Charles Jackson, MD - (charles.jackson.md@adventhealth.com) Kathy Jones - (kathy.d.jones@adventhealth.com) |
| AdventHealth Shawnee Mission Shawnee Mission, Kansas | Obadah Al Chekakie, MD - (MObadah.AlChekakie.MD@AdventHealth.com) Megan Kelly - (Megan.Kelly1@adventhealth.com) |
| Christus Trinity Mother Frances Health System Tyler, Texas | Joshua Rutland, MD - (joshua.rutland@christushealth.org) Carol Cushman - (carol.cushman@christushealth.org) |
| Creighton University Medical Center Omaha, Nebraska | Attila Roka, MD - (attilaroka@creighton.edu) Lois A. Rasmussen - (lois.rasmussen@commonspirit.org) |
| Health University of Utah Salt Lake City, Utah | Ravi Ranjan, MD - (ravi.ranjan@hsc.utah.edu) Audra Eaquinto - (audra.eaquinto@hsc.utah.edu) |
| Henry Ford Health System Detroit, Michigan | Waddah Maskoun, MD - (wmaskou1@hfhs.org) Briita Wanhala - (bwanhal1@hfhs.org) |
| HonorHealth Scottsdale, Arizona | Geoffrey Jao, MD - (gjao@honorhealth.com) Mary Futch Moyer - (mfutch@honorhealth.com) |
| New York-Presbyterian Brooklyn Methodist Hospital Brooklyn, New York | Gioia Turitto, MD - (git9006@nyp.org) Shana Hayes, M.S. - (cmc9055@nyp.org) |
| SUNY Downstate Brooklyn, New York | Adam S Budzikowski, MD - (abudzikowski@downstate.edu) Ann Harris - (ann.harris@downstate.edu) |
| University of Mossouri Columbia, Missouri | Brian Bostick, MD - (bostickb@health.missouri.edu) Charles Donigian - (donigianc@health.missouri.edu) |
| University of Rochester Medical Center Rochester, New York | Amole Ojo, MD - (amole_ojo@urmc.rochester.edu) Samantha Delmartino - (samantha_delmartino@urmc.rochester.edu) |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | Ryan Kipp, MD - (rtkipp@medicine.wisc.edu) Karen Olson - (kjolson@medicine.wisc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Keyur Shah, MD - (keyur.shah@vcuhealth.org) Anna Baranova - (anna.baranova2@vcuhealth.org) |
Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant
Medical Information - medinfo@eidostx.com
NCT06563895
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Key
Inclusion Criteria:
* Male or female ≥ 18 to ≤ 75 years of age inclusive.
* Participants must have an established genotype (hetero- or homozygosity) through a medically-indicated genetic test of a TTR gene variant that is known to be pathogenic or likely pathogenic (eg, V30M/p.V50M, V122I/p.V142I, T60A/p.T80A, or all other pathogenic TTR variants).
* Participant's age is within 10 years younger than or older than PADO.
Key Exclusion Criteria:
* Evidence of ATTR-CM or ATTR-PN.
* Current or past (within last 1 to 12 months, depending on specific agent) treatment with other TTR modifying therapies.
* Contraindication to or inability to undergo cardiac magnetic resonance testing.
* Major organ dysfunction, including: kidney disease, liver disease, heart disease (including cardiomyopathy), neuropathy
* Other diseases or conditions such has cancer within 5 years, untreated hyperthyroidism or hypothyroidism, type 1 diabetes, active hepatitis B or C, HIV.
* Major surgery within the past 3 months or planned during the next 12 months.
* Known hypersensitivity to acoramidis. DRUG: Acoramidis, DRUG: Placebo oral tablet
Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis, Cardiomyopathies, Heart Diseases, Polyneuropathies
Amyloidosis, ATTR-CM, ATTR-PN, Transthyretin, Amyloid, TTR
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Show 104 locations
Study Locations
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| Location | Contacts |
|---|---|
| AP-HP Hopital Bicetre Le Kremlin-Bicêtre, | |
| AP-HP Hopital Henri Mondor Paris, | |
| Aarhus University Hospital Aarhus, | |
| Azienda Ospedaliero Universitaria Policlinico Umberto I Roma, | |
| Azienda Ospedaliero-Universitaria Careggi Florence, | |
| Azienda Ospedaliero-Universitaria Sant'Andrea Rome, | |
| Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico di S.Orsola Bologna, | |
| Boston University (BU) School of Medicine Boston, Massachusetts | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| CAPED - Centro Avancado de Pesquisa, Estudos e Diagnostico Ribeirão Preto, | |
| CHU Bordeaux - Hopital Pellegrin Bordeaux, | |
| CHU de Fort de France Fort-de-France, | |
| CHU de Toulouse - Hopital Rangueil Toulouse, | |
| Cardiopulmonar da Bahia S.A. (Hospital Cardio Pulmonar) Salvador, | |
| Changhua Christian Hospital - Taiwan Changhua, | |
| Charite Universitaetsmedizin Berlin Berlin, | |
| Chu Rennes Rennes Cedes, | |
| Cleveland Clinic Cleveland, Ohio | |
| Cleveland Clinic Florida Stuart, Florida | |
| Columbia University Medical Center New York, New York | |
| Duke University Medical Center Durham, North Carolina | |
| Emory University School Of Medicine Atlanta, Georgia | |
| Erasmus MC Rotterdam, | |
| Fiona Stanley Hospital Murdoch, Western Australia | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore Rome, | |
| Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanità Pubblica - Ospedale San Cataldo Pisa, | |
| Fundacao Centro Medico de Campinas Campinas, | |
| General Hospital of Athens - Alexandra Athens, | |
| HIPPOKRATION General Hospital of Athens Athens, | |
| Henry Ford Health System Detroit, Michigan | |
| Hospital Britanico de Buenos Aires Ciudad de Buenos Aires, Buenos Aires | |
| Hospital Clinico Universitario de Salamanca Salamanca, | |
| Hospital Universitari de Bellvitge L'Hospitalet de Llobregat, | |
| Hospital Universitario Juan Ramon Jimenez Huelva, | |
| Hospital Universitario Puerta de Hierro Majadahonda, | |
| Hospital Universitario Son Llatzer Palma de Mallorca, | |
| Hospital Universitario de A Coruna A Coruña, | |
| ICBA - Instituto Cardiovascular de Buenos Aires S.A. CABA, | |
| Inova Fairfax Hospital Falls Church, Virginia | |
| Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP Cerqueira César, | |
| John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois | |
| Johns Hopkins University Baltimore, Maryland | |
| Kumamoto University Hospital Kumamoto-Shi Chuo-Ku, Kumamoto | |
| Laurelton Heart Specialists Rosedale, New York | |
| Maastricht University Medical Center Maastricht, | |
| Massachusetts General Hospital Lexington, Massachusetts | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | |
| Mayo Clinic - Rochester Rochester, Minnesota | |
| MedStar Washington Hospital Center - MedStar Heart and Vascular Institute Washington D.C., District of Columbia | |
| Medical University of South Carolina (MUSC) Charleston, South Carolina | |
| Mount Sinai Hospital New York, New York | |
| National Institute of Medical Sciences and Nutrition - Salvador Zubiran(INCMNSZ) Tlalpan, | |
| National Neuromuscular Research Institute Austin, Texas | |
| National Taiwan University Hospital Taipei, | |
| National University Hospital - National University Health System Singapore, | |
| New York University (NYU) School of Medicine - Langone Medical Center New York, New York | |
| Norrlands universitetssjukhus (University Hospital of Umea) Umeå, | |
| Oregon Health & Science University Portland, Oregon | |
| Penn Presbyterian Medical Center Philadelphia, Pennsylvania | |
| Princess Alexandra Hospital Woolloongabba, Queensland | |
| Prisma Health Cancer Institute Greenville, South Carolina | |
| Rutgers-Robert Wood Johnson Medical School New Brunswick, New Jersey | |
| Samsung Medical Center Seoul, | |
| Seoul National University Hospital Seoul, | |
| Seoul St. Mary's Hospital Seoul, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Shinshu University Hospital Nagano, Matsumoto, | |
| Singapore General Hospital Singapore, | |
| St Vincent's Hospital Sydney Darlinghurst, New South Wales | |
| St. Bartholomew's Hospital London, | |
| St. Luke's Hospital of Kansas City Kansas City, Missouri | |
| St. Michael's Hospital Toronto, Ontario | |
| Stanford University Stanford, California | |
| Taipei Veterans General Hospital Taipei, | |
| Tallaght University Hospital - The Adelaide and Meath Hospital Dublin, | |
| The Mater Misericordiae University Hospital Dublin, | |
| UZ Leuven Leuven, | |
| Unidade Local de Saude de Santa Maria EPE - Hospital de Santa Maria Lisbon, | |
| Unidade Local de Saude de Santo Antonio EPE - Hospital de Santo Antonio Porto, | |
| UniversitaetsKlinikum Heidelberg Heidelberg, | |
| Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz Mainz, | |
| Universitair Medisch Centrum Utrecht Utrecht, | |
| University College London Hospitals NHS Foundation Trust London, | |
| University Malaya Medical Centre (UMMC) Kuala Lumpur, | |
| University Medical Center Groningen Groningen, | |
| University of British Columbia Vancouver, British Columbia | |
| University of Calgary Calgary, Alberta | |
| University of California, Los Angeles (UCLA) - David Geffen School of Medicine Los Angeles, California | |
| University of California, San Diego (UCSD) - Medical Center La Jolla, California | |
| University of California, San Francisco (UCSF) San Francisco, California | |
| University of Chicago - Medical Center Chicago, Illinois | |
| University of Colorado Anschutz Aurora, Colorado | |
| University of Maryland Medical Center Baltimore, Maryland | |
| University of Miami Miami, Florida | |
| University of Pittsburgh Medical Center, Presbyterian Hospital Pittsburgh, Pennsylvania | |
| University of Texas Southwestern Dallas, Texas | |
| University of Utah Salt Lake City, Utah | |
| University of Washington Medical Center Seattle, Washington | |
| Virginia Commonwealth University Richmond, Virginia | |
| Washington University in St. Louis St Louis, Missouri | |
| Westmead Hospital Northmead, New South Wales | |
| Yale University School of Medicine - Section of Cardiology New Haven, Connecticut | |
| hospital Italiano de Buenos Aires CABA, |
Modeling Mortality in Duchenne Muscular Dystrophy Cardiomyopathy: Identification of Surrogate Outcome Measures for DMD Drug Trials
Jonathan Soslow, MD, MSCI - DMDMachineLearning@vumc.org
NCT07674758
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Inclusion Criteria:
* Clinical phenotype of Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), or muscular dystrophy carrier (MDC) confirmed with muscle biopsy or genotype
Exclusion Criteria:
* Additional genetic or congenital abnormality that may affect cardiovascular function or progression
* Current investigational therapy that may affect cardiovascular function (would preclude ongoing data collection but prior data would still be used) Duchenne Muscular Dystrophy (DMD), Cardiomyopathy, Becker Muscular Dystrophy, Carrier of Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy, cardiomyopathy, machine learning, cardiac MRI, Biomarker, Outcome measures
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Study Locations
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| Location | Contacts |
|---|---|
| Children's Hospital of Richmond at VCU Richmond, Virginia | Study Coordinator - (DMDmachinelearning@vumc.org) |
| Children's National Washington D.C., District of Columbia | Study Coordinator - (DMDmachinelearning@vumc.org) |
| Duke Children's Hospital Durham, North Carolina | Study Coordinator - (DMDmachinelearning@vumc.org) |
| Lurie Children's Chicago, Illinois | |
| Nationwide Children's Columbus, Ohio | Study Coordinator - (DMDmachinglearning@vumc.org) |
| Riley Children's Hospital Indianapolis, Indiana | Study Coordinator - (DMDMachineLearning@vumc.org) |
| Seattle Children's Seattle, Washington | Study Coordinator - (DMDmachinelearning@vumc.org) |
| UC Davis Sacramento, California | Study Coordinator - (DMDmachinelearning@vumc.org) |
| Vanderbilt University Medical Center Nashville, Tennessee | Study Coordinator - (DMDMachineLearning@vumc.org) |