Trials / Completed
CompletedNCT00014079
Genetic Markers in Patients With Colorectal Cancer
Clinical Significance of Genetic Markers in Colon Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 675 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | DNA stability analysis | |
| GENETIC | loss of heterozygosity analysis | |
| GENETIC | microsatellite instability analysis |
Timeline
- Start date
- 1997-09-01
- Primary completion
- 2003-07-01
- Completion
- 2005-05-01
- First posted
- 2003-01-27
- Last updated
- 2016-07-13
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00014079. Inclusion in this directory is not an endorsement.