Protocol for a Research Sample Repository for Hematopoiet... | NCT04920474

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

NCT04920474

Sponsor

Center for International Blood and Marrow Transplant Research

Status

Recruiting

Last Update Posted

May 3, 2023Actual

Enrollment

99,999,999Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1991Actual

Primary Completion Date

Jul 2030Estimated

Completion Date

Jul 2030Estimated

First Submitted Date

Jun 3, 2021

First Submission Date that Met QC Criteria

Jun 3, 2021

First Posted Date

Jun 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2023

Last Update Posted Date

May 3, 2023Actual

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

99,999,999Estimated

Measure	Description	Time Frame
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 Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Ashley Spahn	Contact			RepositoryIRB@NMDP.ORG

Name	Affiliation	Role
Stephen Spellman	NMDP Be The Match/CIBMTR	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
NMDP Biorepository	Recruiting	New Brighton	Minnesota	55112	United States

Label	URL
Research Sample Repository Protocol	View source

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.