Investigating Cytokine Genes of Stem Cell Donors

NCT00353821 | Completed

• 2 other identifiers: 03020103-H-0201
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to investigate the factors that may account for the differences in the way a stem cell recipient s immune system works after a transplant. It will focus on cytokine genes, which give specific instructions to the genes and which may influence immune system response. More specifically, the purpose of the study is to find out how gene polymorphisms (gene variations among the population) affect the success or failure of a stem cell transplant. Study participants will have donated blood for a stem cell transplant. They will be asked to give consent for NIH personnel to run special tests on these blood samples, which will have been placed in storage. It is hoped that blood samples will be studied from 600 stem cell donors.

Conditions

Stem Cell Transplantation

Keywords

Tumor Necrosis Factor Alpha (TNF-Alpha); Interferon-Gamma (IFN-Gamma); Interleukin-10 (IL-10); Interleukin-6 (IL-6); Interleukin-1 (IL-1 Ra); Interleukin-1 Receptor Antagonist (IL-1 Ra); Vitamin D Receptor (VitD R)

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation as a stem cell donor on a Hematology Branch protocol.
• For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian. Informed assent from minors: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.
• Age greater than or equal to 2 and less than or equal to 80.

You may not qualify if:

• Subjects unable to comprehend the investigational nature of the laboratory research.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Socie G, Loiseau P, Tamouza R, Janin A, Busson M, Gluckman E, Charron D. Both genetic and clinical factors predict the development of graft-versus-host disease after allogeneic hematopoietic stem cell transplantation. Transplantation. 2001 Aug 27;72(4):699-706. doi: 10.1097/00007890-200108270-00024.

  PMID: 11544434 BACKGROUND

• Cavet J, Middleton PG, Segall M, Noreen H, Davies SM, Dickinson AM. Recipient tumor necrosis factor-alpha and interleukin-10 gene polymorphisms associate with early mortality and acute graft-versus-host disease severity in HLA-matched sibling bone marrow transplants. Blood. 1999 Dec 1;94(11):3941-6.

  PMID: 10572111 BACKGROUND

• Cavet J, Dickinson AM, Norden J, Taylor PR, Jackson GH, Middleton PG. Interferon-gamma and interleukin-6 gene polymorphisms associate with graft-versus-host disease in HLA-matched sibling bone marrow transplantation. Blood. 2001 Sep 1;98(5):1594-600. doi: 10.1182/blood.v98.5.1594.

  PMID: 11520812 BACKGROUND

Study Officials

• A. John Barrett, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 19, 2006
• Study Start: June 5, 2003
• Study Completion: March 2, 2018
• Last Updated: December 12, 2019

Record last verified: 2018-03-02

Locations

US (1)