Studying DNA and Outcome in Patients With Advanced Colorectal Cancer Treated With Fluorouracil and Oxaliplatin With or Without Bevacizumab on Clinial Trial E-3200
|ClinicalTrials.gov Identifier: NCT00897819|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 19, 2017
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.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Genetic: DNA methylation analysis Genetic: loss of heterozygosity analysis Genetic: microsatellite instability analysis Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||350 participants|
|Official Title:||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|
|Actual Study Start Date :||January 3, 2007|
|Actual Primary Completion Date :||January 30, 2008|
|Actual Study Completion Date :||January 30, 2008|
- Correlation of MSI and LOH to outcome and response [ Time Frame: 1 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897819
|Study Chair:||Stanley Hamilton, MD||M.D. Anderson Cancer Center|