Clinical Trials Directory

Trials / Completed

CompletedNCT00897819

Studying DNA and Outcome in Patients With Advanced Colorectal Cancer Treated With Fluorouracil and Oxaliplatin With or Without Bevacizumab on Clinial Trial E-3200

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

Status
Completed
Phase
Study type
Observational
Enrollment
350 (actual)
Sponsor
ECOG-ACRIN Cancer Research Group · Network
Sex
All
Age
18 Years – 120 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
GENETICDNA methylation analysis
GENETICloss of heterozygosity analysis
GENETICmicrosatellite instability analysis
OTHERlaboratory biomarker analysis

Timeline

Start date
2007-01-03
Primary completion
2008-01-30
Completion
2008-01-30
First posted
2009-05-12
Last updated
2017-05-19

Source: ClinicalTrials.gov record NCT00897819. Inclusion in this directory is not an endorsement.