Genetic Markers in Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00014079
First received: April 10, 2001
Last updated: July 4, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Colorectal Cancer
Genetic: DNA stability analysis
Genetic: loss of heterozygosity analysis
Genetic: microsatellite instability analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Significance of Genetic Markers in Colon Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Determine the clinical and pathologic significance of unstable DNA elements [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the clinical and pathologic significance of loss of heterozygosity [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 675
Study Start Date: September 1997
Study Completion Date: May 2005
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1

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 Genetic: loss of heterozygosity analysis Genetic: microsatellite instability analysis

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients have resectable adenocarcinoma of the colon or rectum and has been previously enrolled on N784852, N794604, N844652, N864751, N874651, and N894651.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014079

Locations
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Steven R. Alberts, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00014079     History of Changes
Other Study ID Numbers: NCCTG-934655, CDR0000065549
Study First Received: April 10, 2001
Last Updated: July 4, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on July 29, 2015