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

Study 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.

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

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Genetic: DNA methylation analysis
* Genetic: loss of heterozygosity analysis
* Genetic: microsatellite instability analysis
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the colon or rectum Advanced disease Enrolled on clinical trial E-3200 and received fluorouracil and oxaliplatin Tumor tissue blocks available Routine pathology specimens (i.e., blood, urine) available PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA methylation analysis|nan|
|Genetic: loss of heterozygosity analysis|nan|
|Genetic: microsatellite instability analysis|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of MSI and LOH to outcome and response |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent colon cancer, recurrent rectal cancer, stage III colon cancer, stage III rectal cancer, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum