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

NCT ID: NCT04920474

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

99999999 participants

Study Classification

OBSERVATIONAL

Study Start Date

1991-07-31

Study Completion Date

2030-07-31

Brief Summary

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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

Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center for International Blood and Marrow Transplant Research

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Spellman

Role: PRINCIPAL_INVESTIGATOR

NMDP Be The Match/CIBMTR

Locations

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NMDP Biorepository

New Brighton, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ashley Spahn

Role: CONTACT

Facility Contacts

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Liz Weideman

Role: primary

651-745-5036

Related Links

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Other Identifiers

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NMDP IRB-1991-0002

Identifier Type: -

Identifier Source: org_study_id

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