Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)
Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT CTN #1202)
3 other identifiers
observational
1,860
1 country
42
Brief Summary
The goal of this protocol is to establish a cohort of at least 1500 biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared bio specimen resource for conducting future allogeneic hematopoietic stem cell transplantation (HCT) correlative studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Typical duration for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
May 29, 2018
CompletedDecember 9, 2022
December 1, 2022
3.3 years
June 11, 2013
March 26, 2018
December 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Providing Biologic Samples
The primary outcome will be measured by the number of participants who supply biologic samples. The prospectively collected samples will be a shared bio specimen resource for conducting future correlative studies.
Two years from hematopoietic stem cell transplant
Eligibility Criteria
All U.S. Allogeneic Transplant Donors and Recipients weighing 20 or more kg may participate in the collection of samples.
You may qualify if:
- Recipients of first allogeneic hematopoietic cell transplants that are transplanted in U.S. centers that participate in the NMDP/CIBMTR's "Protocol for a Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries" and receive a cord blood graft or receive a bone marrow or peripheral blood graft from a related donor or from an unrelated donor in an NMDP-affiliated Donor Center or Registry participating in that same protocol.
- 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
- 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.
- 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).
- 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".
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- National Cancer Institute (NCI)collaborator
- Blood and Marrow Transplant Clinical Trials Networkcollaborator
- National Marrow Donor Programcollaborator
Study Sites (42)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Children's Hospital at Oakland
Oakland, California, 94609, United States
University of CA, SF
San Francisco, California, 94143, United States
Stanford Hospitals and Clinics
Stanford, California, 94305, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Emory University
Atlanta, Georgia, 30322, United States
BMT at Northside Hospital
Atlanta, Georgia, 30342, United States
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Johns Hopkins
Baltimore, Maryland, 21231, United States
DFCI/Brigham & Women's
Boston, Massachusetts, 02115, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48105-2967, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University/St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park
Buffalo, New York, 14263, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27705, United States
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State/Arthur G. James Cancer Hospital
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Cook Children's Hospital
Fort Worth, Texas, 76104, United States
Baylor College of Medicine/The Methodist Hospital
Houston, Texas, 77030, United States
University of Texas/MD Anderson CRC
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Utah BMT/Primary Children's Medical Center
Salt Lake City, Utah, 84132, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Related Publications (1)
Bhasin-Chhabra B, Wang T, Levine JE, Shenoy S, Perales MA, Bashey A, Raff H, Saber W. Soluble urokinase plasminogen activator receptor and acute kidney injury in hematopoietic cell transplantation. Blood Adv. 2025 Dec 23;9(24):6394-6401. doi: 10.1182/bloodadvances.2025016655.
PMID: 40991367DERIVED
Biospecimen
10mL serum for Proteomic studies for patients at the following time points: pre-transplant, days 7, 14, 21, 28, 42, 56, and 90. Gene Expression studies will include the following: * PAXgene Lysates-source whole blood RNA (15 ml blood) for 240 patients collected on days 21, 56, and 90. * CytoChex tube for Immunophenotyping (4-5 mL blood) collected on days 21, 56, and 90.
Results Point of Contact
- Title
- Adam Mendizabal, PhD
- Organization
- The Emmes Corporation
Study Officials
- STUDY DIRECTOR
Mary Horowitz, MD, MS
Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2013
First Posted
June 17, 2013
Study Start
June 1, 2013
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
December 9, 2022
Results First Posted
May 29, 2018
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Within 6 months of official study closure at participating sites.
- Access Criteria
- Available to the public.
Findings will be published in a manuscript.