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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04920474
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

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

Condition or disease
Autologous Stem Cell Transplantation Allogeneic Stem Cell Transplantation Cellular Therapy Marrow Toxic Injury

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

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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 2025
Estimated Study Completion Date : July 2025



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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.


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

Information from the National Library of Medicine

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


Contacts
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Contact: Ashley Spahn RepositoryIRB@NMDP.ORG

Locations
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United States, Minnesota
NMDP Biorepository Recruiting
New Brighton, Minnesota, United States, 55112
Contact: Liz Weideman    651-745-5036    ewiedenm@nmdp.org   
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
Investigators
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Principal Investigator: Stephen Spellman NMDP Be The Match/CIBMTR
Additional Information:
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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: June 9, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries