Status:
COMPLETED
Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Conditions:
Allogeneic Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
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 co...
Detailed Description
The goal of this protocol is to establish a cohort of biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared bio specimen resource for conducting futur...
Eligibility Criteria
Inclusion
- 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".
Exclusion
- N/A
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
1860 Patients enrolled
Trial Details
Trial ID
NCT01879072
Start Date
June 1 2013
End Date
September 1 2016
Last Update
December 9 2022
Active Locations (42)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
Children's Hospital at Oakland
Oakland, California, United States, 94609
4
University of CA, SF
San Francisco, California, United States, 94143