Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant

Vanderbilt University Medical Center

Status

Terminated

Conditions

Cancer

Treatments

Other: laboratory biomarker analysis

Genetic: polymorphism analysis

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00957736

IRB# 080995

P30CA068485 (U.S. NIH Grant/Contract)

VU-VICC-BMT-0867

VICC BMT 0867

Details and patient eligibility

About

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.

PURPOSE: This phase I trial is studying chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.

Full description

OBJECTIVES:

To determine and define the biological basis of different subtypes of chronic graft-vs-host disease using a targeted single nucleotide polymorphisms approach in patients who have undergone allogeneic stem cell transplantation.

OUTLINE: Two important aspects of the methodologies that will be employed for the analysis of SNPs associated with GVHD are throughput efficiency to be able to perform the assays on a reasonable number of samples as well as having the ability to add or remove SNPs to the assay panel. While a genome-wide association study to identify variants associated with GVHD would offer an unbiased approach, our patient cohort size would not allow significant statistical power in the study. Therefore, a more targeted approach using two established technologies is proposed.

The Sequenome assay uses the unique combination of a single-base primer extension assay incorporating one of four modified nucleotides. The four modified nucleotides each have a unique mass that allows them to be distinguished from one another using mass spectrometry. Each SNP is determined analyzing the primer extension product from a PCR amplicon that surrounds the SNP of interest. The development of each assay involves designing flanking PCR primers and an internal extension assay using web-based software provided by Sequenome. The assays can be designed to analyze up to 30 SNPs in a single reaction, providing a customizable, efficient and high-throughput assay for SNPs of interest.

Enrollment

252 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Underwent prior matched related or unrelated allogeneic stem cell transplantation (SCT)
- Presence OR absence of chronic graft-vs-host disease after day 100 and alive after day 180 post-transplantation
No T-cell depleted SCT, cord blood transplantation, mismatched allogeneic transplantation, or autologous transplantation
Available recipient and donor DNA (samples collected from the Vanderbilt University or the Fred Hutchinson Cancer Center tissue bank)

PATIENT CHARACTERISTICS: