RATIONALE: Determination of genetic markers for colorectal cancer may help doctors to identify patients who are at risk. PURPOSE: Genetic testing study of patients and families with a history of colorectal cancer to identify patients who are at risk of developing colorectal cancer.

Condition	Treatment or Intervention
Colon Cancer Gastrointestinal Cancer Rectal Cancer	Procedure: genetics

Further Study Details: 

OBJECTIVES: I. Select patients with colon cancer and families at high-risk for colon cancer and collect leukocyte DNA, immortalized cell lines, plasma, and tumor specimens from these individuals and from control individuals. II. Develop patient education, counseling, and follow up plans for these individuals. III. Compare the frequency of defective DNA mismatch repair in individuals with familial colon cancer versus all colon cancers by using antibodies to the hMSH2 and hMLH1 protein products.

PROTOCOL OUTLINE: This is a multicenter study. Patients, family members, and control individuals complete an extended telephone interview, an extended personal interview, and an epidemiological survey, and contribute a blood specimen. Blood and tumor specimens are examined for the specific pattern of immunohistochemical expression of hMSH2 and HMLH1 to determine the frequency or lack of expression of these two protein products. Patients may be contacted periodically (about every 3 years) to update information about health, health practices, and family history. Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: At least 500-600 families (approximately 1500 patients) and the same number of matched controls will be accrued for this study.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Primary colorectal cancer and participating in one of the following NCCTG protocols: NCCTG-784852: No Treatment Control Versus Levamisole Versus Levamisole Plus 5-Fluorouracil; NCCTG-794604: No Treatment Control Versus 5-FU by Portal Vein Infusion; NCCTG-794751: Postoperative Radiation Versus Postoperative Radiation Plus Sequential Chemotherapy with Methyl CCNU and 5-FU; NCCTG-844652: An Intergroup Study - An Evaluation of Levamisole Alone or Levamisole Plus 5-Fluorouracil as Surgical Adjuvant Treatment for Resectable Adenocarcinoma of the Colon; NCCTG-864751: Phase III Protocol for Surgical Adjuvant Therapy of Rectal Carcinoma: A Controlled Evaluation of (A) Protracted-Infusion-5-Fluorouracil (5-FU) as a Radiation Enhancer and (B) 5-FU Plus Methyl-CCNU Chemotherapy; NCCTG-874651: M/N - A Controlled Evaluation of Recombinant Interferon-Gamma (IFN-GM) and 5-FU and Folinic Acid With or Without Levamisole as Adjuvant Treatment for Resectable Adenocarcinoma of the Colon; NCCTG-894651: A Controlled Phase III Evaluation of 5-Fluorouracil with Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer; NCCTG-914653: A Phase III Evaluation of High-Dose Levamisole Plus 5-Fluorouracil and Leucovorin as Surgical Adjuvant Therapy for High-Risk Colon Cancer
• Adequate tissue for review OR Families of patients meeting the above criteria OR Colon cancer patient and population controls not in a high-risk family OR Spouse of a high-risk colon cancer patient

--Prior/Concurrent Therapy--

• See Disease Characteristics

--Patient Characteristics--

• Age: Not specified
• Performance status: See Disease Characteristics
• Life expectancy: See Disease Characteristics
• Hematopoietic: See Disease Characteristics
• Hepatic: See Disease Characteristics
• Renal: See Disease Characteristics

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Minnesota
      CentraCare Clinic, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
North Dakota
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States
Canada, Saskatchewan
      Allan Blair Cancer Centre, Regina,  Saskatchewan,  S4T 7T1,  Canada

Study chairs or principal investigators

Noralane M. Lindor,  Study Chair,  North Central Cancer Treatment Group   

Study ID Numbers:  CDR0000066737; NCCTG-974655
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003648
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08