Protocol for a Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

NCT04920474 | Recruiting

• 1 other identifier: NMDP IRB-1991-0002
• Study Type: observational
• Target: 99,999,999
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autologous Stem Cell Transplantation; Allogeneic Stem Cell Transplantation; Cellular Therapy; Marrow Toxic Injury

Outcome Measures

Primary Outcomes (1)

• To make blood samples available for research studies related to histocompatibility and HCT or other cellular therapy

  pre-HCT (recipient) or pre-donation (donor)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recipients and Donors that are involved with a stem cell transplantation process

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Center for International Blood and Marrow Transplant Research: lead

Study Sites (1)

NMDP Biorepository

New Brighton, Minnesota, 55112, United States

RECRUITING

Related Links

• Research Sample Repository Protocol

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.

Study Officials

• Stephen Spellman

  NMDP Be The Match/CIBMTR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Spahn

CONTACT

RepositoryIRB@NMDP.ORG

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 9, 2021
• Study Start: July 1, 1991
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: May 3, 2023

Record last verified: 2023-03

Locations

US (1)