Protocol for a Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
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ClinicalTrials.gov Identifier: NCT04920474 |
Recruitment Status :
Recruiting
First Posted : June 9, 2021
Last Update Posted : May 3, 2023
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The primary purpose of the Research Sample Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cell transplantation (HCT) or other cellular therapy.
Representatives of participating centers and investigators or research groups may request access to research samples contained in the Research Sample Repository for the purpose of conducting research including:
- investigating molecular explanations for histocompatibility or clinical outcomes through analysis of genomic, epigenetic, or other biomolecular data
- evaluating the factors that affect transplant or cellular therapy outcome
- studying the distribution of HLA tissue types in different populations
- studying the success of transplantation, cellular therapies or supportive care in the management of marrow toxic injuries
- performing de-linked (anonymous) research
Condition or disease |
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Autologous Stem Cell Transplantation Allogeneic Stem Cell Transplantation Cellular Therapy Marrow Toxic Injury |
Study Type : | Observational |
Estimated Enrollment : | 99999999 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
Official Title: | Protocol for a Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries |
Actual Study Start Date : | July 1991 |
Estimated Primary Completion Date : | July 2030 |
Estimated Study Completion Date : | July 2030 |
- To make blood samples available for research studies related to histocompatibility and HCT or other cellular therapy [ Time Frame: pre-HCT (recipient) or pre-donation (donor) ]
Biospecimen Retention: Samples With DNA
Up to thirty milliliters (30 mL) of blood are collected from adult patients and adult donors. For pediatric patients where the collection of the full sample is medically contraindicated, as little as one milliliter (1 mL) of blood may be collected.
In cases where donor or patient blood samples are not available, samples may consist of any material that could potentially yield testable DNA. Types may include red cell pellets, extracted DNA, dried blood on filter paper, viable cells, and any other testable material.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Eligibility to participate in the Research Sample Repository Protocol:
Hematopoietic Cell (HC) or Other Cellular Therapy Donors
- Donors are eligible to participate in the Research Sample Repository if they have donated or are scheduled to donate HCs or cellular therapy products to an allogeneic recipient either by a marrow harvest or by apheresis. This includes adults with and without decision making capacity and children.
- All donors registered on the National Marrow Donor Program (NMDP) Registry, regardless of whether they have been requested to donate a product for a patient, are eligible to participate in the Research Sample Repository.
Cord Blood Units (CBUs)
- Testable material from CBUs (Specimens) infused at treatment centers covered under the C. W. Bill Young Transplantation Program are eligible for inclusion in the Research Sample Repository. Material may be submitted by participating treatment centers, centralized laboratories and Cord Blood Banks.
Hematopoietic Cell Transplantation or Other Cellular Therapy Recipients
- All U.S. recipients of allogeneic or autologous HC transplants or cellular therapies are eligible to participate in the Research Sample Repository. This includes adults with and without decision making capacity and children.
Patients with Marrow Toxic Injury
- Any patient who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Treatment Network (RITN) is eligible to participate in the Research Sample Repository. This includes adults with and without decision-making capacity and children.
- Eligible patients may have received support care only, growth factor support, hematopoietic stem cell transplant or other appropriate medical treatment for marrow toxic injury
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): NCT04920474
Contact: Ashley Spahn | RepositoryIRB@NMDP.ORG |
United States, Minnesota | |
NMDP Biorepository | Recruiting |
New Brighton, Minnesota, United States, 55112 | |
Contact: Liz Weideman 651-745-5036 ewiedenm@nmdp.org |
Principal Investigator: | Stephen Spellman | NMDP Be The Match/CIBMTR |
Responsible Party: | Center for International Blood and Marrow Transplant Research |
ClinicalTrials.gov Identifier: | NCT04920474 |
Other Study ID Numbers: |
NMDP IRB-1991-0002 |
First Posted: | June 9, 2021 Key Record Dates |
Last Update Posted: | May 3, 2023 |
Last Verified: | March 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Wounds and Injuries |