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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
Sponsor:
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

Tracking Information
First Submitted Date June 3, 2021
First Posted Date June 9, 2021
Last Update Posted Date May 3, 2023
Actual Study Start Date July 1991
Estimated Primary Completion Date July 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2021)		 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) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.
Sampling Method Non-Probability Sample
Study Population Recipients and Donors that are involved with a stem cell transplantation process
Condition
  • Autologous Stem Cell Transplantation
  • Allogeneic Stem Cell Transplantation
  • Cellular Therapy
  • Marrow Toxic Injury
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 3, 2021)		 99999999
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2030
Estimated Primary Completion Date July 2030   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Ashley Spahn RepositoryIRB@NMDP.ORG
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04920474
Other Study ID Numbers NMDP IRB-1991-0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Center for International Blood and Marrow Transplant Research
Original Responsible Party Same as current
Current Study Sponsor Center for International Blood and Marrow Transplant Research
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Stephen Spellman NMDP Be The Match/CIBMTR
PRS Account Center for International Blood and Marrow Transplant Research
Verification Date March 2023