Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)
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| ClinicalTrials.gov Identifier: NCT01879072 |
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Recruitment Status :
Completed
First Posted : June 17, 2013
Results First Posted : May 29, 2018
Last Update Posted : December 9, 2022
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| Condition or disease |
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| Allogeneic Hematopoietic Stem Cell Transplantation |
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 future allogeneic HCT correlative studies. This resource is designed to allow genomic, proteomic and transcriptional data to be integrated with high quality clinical phenotype and outcomes data to identify risk factors for development and severity of acute GVHD, chronic GVHD, organ toxicity, relapse, mortality, infection and other clinically significant complications occurring after allogeneic HCT.
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.
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 1860 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT CTN #1202) |
| Actual Study Start Date : | June 2013 |
| Actual Primary Completion Date : | September 2016 |
| Actual Study Completion Date : | September 2016 |
- Number of Participants Providing Biologic Samples [ Time Frame: Two years from hematopoietic stem cell transplant ]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.
Biospecimen Retention: Samples With DNA
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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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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 Criteria:
- N/A
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879072
Show 42 study locations
| Study Director: | Mary Horowitz, MD, MS | Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin |
Documents provided by Medical College of Wisconsin:
| Responsible Party: | Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT01879072 |
| Other Study ID Numbers: |
BMTCTN1202 U10HL069294-11 ( U.S. NIH Grant/Contract ) 5U24CA076518 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 17, 2013 Key Record Dates |
| Results First Posted: | May 29, 2018 |
| Last Update Posted: | December 9, 2022 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Findings will be published in a manuscript. |
| Time Frame: | Within 6 months of official study closure at participating sites. |
| Access Criteria: | Available to the public. |
| URL: | https://biolincc.nhlbi.nih.gov/home/ |
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Biomarkers Hematopoietic stem cell transplant |