Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)
NCT ID: NCT01879072
Last Updated: 2022-12-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
1860 participants
OBSERVATIONAL
2013-06-30
2016-09-30
Brief Summary
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Detailed Description
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To achieve this goal, patients and donors will be recruited and consent obtained at the time that they enroll on BMT CTN protocols where enrollment occurs at or before transplantation or prior to start of conditioning for patients enrolled on non-BMT CTN studies or treated as standard of care. Samples will be collected: (1) from patients and donors pre-transplant; and, (2) from patients post-transplant on a calendar schedule through the first 3 months post-HCT. For patients co-enrolled on BMT CTN studies, clinical data will be collected in the context of the primary transplant protocols. For patients not enrolled on BMT CTN protocols, clinical data on early post-transplant events will be collected using the same data collection forms and systems that are used on BMT CTN trials. Additional clinical data for both BMT CTN and non-BMT CTN patients will be available from data submitted to the Center for International Blood and Marrow Transplant Research (CIBMTR) using the CIBMTR Comprehensive Report Forms. This protocol also leverages ongoing pre-transplant donor-recipient sample collection performed by the CIBMTR and National Marrow Donor Program (NMDP). Success in establishing this shared resource will inspire future investigator initiated research proposals and will allow investigators to take advantage of National Institutes of Health (NIH) funding initiatives.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
This transplant and donor center restriction is to allow linkage with pretransplant donor specimens collected under the NMDP/CIBMTR protocol. Current data indicate that \>90% of donors approached under this protocol agree to provide samples
2. Patients with any malignant or non-malignant hematologic disorder will be eligible for enrollment on this protocol. A subset of 240 sequential patients with acute leukemia in first or second remission will also provide research samples for gene expression studies.
3. Children may participate in this study but must weigh at least 20 kilograms given the volume (100ml) and number of blood draws during this study. Subjects must weigh at least 30 kg to provide research samples for gene expression studies (additional 40 ml).
4. All participants or parent/legal guardian must sign an informed consent for this study.
Because studies using this resource will require linking with clinical data collected by CIBMTR, all participants or parent/legal guardian must also consent to participate in "Protocol for a Research Database for Hematopoietic Cell Transplantation and Marrow Toxic Injuries".
Exclusion Criteria
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Cancer Institute (NCI)
NIH
Blood and Marrow Transplant Clinical Trials Network
NETWORK
National Marrow Donor Program
OTHER
Medical College of Wisconsin
OTHER
Responsible Party
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Principal Investigators
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Mary Horowitz, MD, MS
Role: STUDY_DIRECTOR
Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Children's Hospital at Oakland
Oakland, California, United States
University of CA, SF
San Francisco, California, United States
Stanford Hospitals and Clinics
Stanford, California, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida College of Medicine (Shands)
Gainesville, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
BMT at Northside Hospital
Atlanta, Georgia, United States
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Johns Hopkins
Baltimore, Maryland, United States
DFCI/Brigham & Women's
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University/Barnes Jewish Hospital
St Louis, Missouri, United States
Washington University/St. Louis Children's Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park
Buffalo, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State/Arthur G. James Cancer Hospital
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Cook Children's Hospital
Fort Worth, Texas, United States
Baylor College of Medicine/The Methodist Hospital
Houston, Texas, United States
University of Texas/MD Anderson CRC
Houston, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Utah BMT/Primary Children's Medical Center
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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