Genetic Markers in Patients With Colorectal Cancer

Study Overview
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Brief Summary
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RATIONALE: Determination of genetic markers for colorectal cancer may improve the identification of patients who are at highest risk for relapse. PURPOSE: This clinical trial is studying the importance of genetic markers for detecting relapse in patients with colorectal cancer.

Detailed Description
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OBJECTIVES: Determine the clinical and pathologic significance of unstable DNA elements in colorectal cancer (tumor microsatellite instability). Determine the clinical and pathologic significance of loss of heterozygosity for chromosomes 5, 8, 17, and 18 (as the primary targets) and of chromosomes 1, 14, and 22 (as the secondary targets) in colorectal cancer. OUTLINE: DNA is examined for unstable elements (microsatellite instability and loss of heterozygosity) by analyzing at least 10 separate (CA)n-repeats localized to 5 separate chromosomes (5q, 8p, 15, 17p, and 18q). Loss of heterozygosity is analyzed for at least four chromosomal arms (5q, 8p, 17p, and 18q) and later other chromosomes (e.g., 1, 14, and 22). Immunohistochemistry is used to test for the presence or absence of the genes involved in DNA mismatch repair (hMLH1 and hMSH2). Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. PROJECTED ACCRUAL: This study will accrue up to 708 specimens.

Official Title
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Clinical Significance of Genetic Markers in Colon Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Genetic: DNA stability analysis
* Genetic: loss of heterozygosity analysis
* Genetic: microsatellite instability analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Must have had a resectable adenocarcinoma of the colon or rectum and must have participated in one of the following NCCTG randomized clinical trials: 784852: No Treatment Control Versus Levamisole Versus Levamisole Plus Fluorouracil (5-FU) 794604: No Treatment Control Versus 5-FU by Portal Vein Infusion 794751: Postoperative Radiation Versus Postoperative Radiation Plus Sequential Chemotherapy with Methyl CCNU and 5-FU 844652: An Intergroup Study - An Evaluation of Levamisole Plus 5-FU as Surgical Adjuvant Treatment for Resectable Adenocarcinoma of the Colon 864751: Phase III Protocol for Surgical Adjuvant Therapy of Rectal Carcinoma: A Controller Evaluation of (A) Protracted-Infusion 5-FU as a Radiation Enhancer and (B) 5-FU Plus Methyl-CCNU Chemotherapy 874651: M/N - A Controller Evaluation of Recombinant Interferon-gamma (IFL GM) and 5-FU and Folinic Acid With or Without Levamisole as Adjuvant Treatment for Resectable Adenocarcinoma of the Colon 894651: A Controller Phase III Evaluation of 5-FU Combined With Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer Tissue blocks from the primary colorectal cancer must have been received by the NCCTG operations office
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>DNA is examined for unstable elements (microsatellite instability and loss of heterozygosity) by analyzing at least 10 separate (CA)n-repeats localized to 5 separate chromosomes (5q, 8p, 15, 17p, and 18q). Loss of heterozygosity is analyzed for at least four chromosomal arms (5q, 8p, 17p, and 18q) and later other chromosomes (e.g., 1, 14, and 22). Immunohistochemistry is used to test for the presence or absence of the genes involved in DNA mismatch repair (hMLH1 and hMSH2). Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. | Genetic: DNA stability analysis<br> <br> Genetic: loss of heterozygosity analysis<br> <br> Genetic: microsatellite instability analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the clinical and pathologic significance of unstable DNA elements |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the clinical and pathologic significance of loss of heterozygosity |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer