Colorectal Cancer Clinical Trial
Official title:
The Familial Colorectal Neoplasia Collaborative Group
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.
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.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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