Clinical trial NCT04920474: Protocol for a Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Official title: Protocol for a Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autologous Stem Cell Transplantation
Allogeneic Stem Cell Transplantation
Cellular Therapy
Marrow Toxic Injury
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
First posted: 2021-06-09
Enrollment: 99999999
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recipients and Donors that are involved with a stem cell transplantation process

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

Detailed description: Research samples will be accepted from the following four categories:

* Hematopoietic Cell or other Cellular Therapy Donors
* Cord Blood Units
* Hematopoietic Cell Transplantation or other Cellular Therapy Recipients
* Patients with Marrow Toxic Injury

Eligibility criteria: 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

Primary outcomes:
measure: To make blood samples available for research studies related to histocompatibility and HCT or other cellular therapy
timeFrame: pre-HCT (recipient) or pre-donation (donor)
Secondary outcomes:
Other outcomes:
Locations:
city: New Brighton
country: United States
facility: NMDP Biorepository
state: Minnesota
Study officials:
affiliation: NMDP Be The Match/CIBMTR
name: Stephen Spellman
role: PRINCIPAL_INVESTIGATOR
References: