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Clinical Trials/NCT00897819
NCT00897819
Completed
Not Applicable

Evaluation of the Association Between DNA Methylation and Shortened Survival in Patients With Advanced Colorectal Cancer Treated With 5-FU/Oxaliplatin-Based Regimens in E3200

ECOG-ACRIN Cancer Research Group0 sites350 target enrollmentJanuary 3, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
ECOG-ACRIN Cancer Research Group
Enrollment
350
Primary Endpoint
Correlation of MSI and LOH to outcome and response
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

RATIONALE: Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is analyzing the DNA in tissue samples from patients with advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.

Detailed Description

OBJECTIVES: * Determine the CpG island methylation pathway markers that are adverse for survival after treatment with fluorouracil in patients with advanced colorectal adenocarcinoma treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200. * Compare the methylation results to clinicopathologic and molecular findings and survival. OUTLINE: This is a multicenter study. Tissue, blood, and urine samples and genomic DNA samples from tumor tissue blocks are examined by pyrosequencing assay for methylation. Genes examined include MINT1, MINT31, P14, and P16. Microsatellite instability and loss of heterozygosity (LOH) on chromosome 18 (18q LOH) are also assessed. Microsatellites examined include BAT loci, TGFβRII, D2S123, D55346, and D17S250. PROJECTED ACCRUAL: A total of 350 specimens will be accrued for this study.

Registry
clinicaltrials.gov
Start Date
January 3, 2007
End Date
January 30, 2008
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ECOG-ACRIN Cancer Research Group
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Correlation of MSI and LOH to outcome and response

Time Frame: 1 month

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