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Genetic Markers in Patients With Colorectal Cancer

This study has been completed.
Study NCT00014079.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Genetic Markers in Patients With Colorectal Cancer
Official Title † Clinical Significance of Genetic Markers in Colon Cancer
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.
Study Phase
Study Type † Observational
Study Design †
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Colorectal Cancer
Intervention † Procedure: DNA stability analysis
Procedure: loss of heterozygosity analysis
Procedure: microsatellite instability analysis
MEDLINE PMIDs 12867608
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Completed
Enrollment †
Start Date † September 1997
Completion Date
Eligibility Criteria †

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

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00014079
Organization ID CDR0000065549
Secondary IDs †† NCCTG-934655
Study Sponsor † North Central Cancer Treatment Group
Collaborators †† National Cancer Institute (NCI)
Investigators †
Study Chair:     Steven R. Alberts, MD     Mayo Clinic    
Information Provided By National Cancer Institute (NCI)
Verification Date June 2005
First Received Date † April 10, 2001
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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