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Clinical Trials/NCT00014079
NCT00014079
Completed
Not Applicable

Clinical Significance of Genetic Markers in Colon Cancer

Alliance for Clinical Trials in Oncology3 sites in 1 country675 target enrollmentSeptember 1997

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Alliance for Clinical Trials in Oncology
Enrollment
675
Locations
3
Primary Endpoint
Determine the clinical and pathologic significance of unstable DNA elements
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 1997
End Date
May 2005
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Determine the clinical and pathologic significance of unstable DNA elements

Time Frame: Up to 5 years

Secondary Outcomes

  • Determine the clinical and pathologic significance of loss of heterozygosity(Up to 5 years)

Study Sites (3)

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