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

Terminated

• Conditions: Cancer
• Interventions: Genetic: polymorphism analysis; Other: laboratory biomarker analysis

• Registration Number: NCT00957736
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-11
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allogeneic stem cell transplant	laboratory biomarker analysis	Stem cells from a genetically non-identical donor transplanted into a patient.
Allogeneic stem cell transplant	polymorphism analysis	Stem cells from a genetically non-identical donor transplanted into a patient.

Primary Outcome Measures

Name	Time	Method
To study the SNP profiles of a select group of candidate non-HLA genes among various cGVHD subtypes. Patients will be stratified as having classic cGVHD vs. non-classic GVHD for initial analyses.	Upon data collection of final patient

Secondary Outcome Measures

Name	Time	Method
Correlation of SNP profiles with predominant organ involvement and responsiveness of cGVHD to therapy	Upon collection of data on final patient
Correlation of SNP profiles with survival endpoints	Upon collection of data on final patient

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States