NCT00003648

Genetic Study of Patients and Families With a History of Colorectal Cancer

The Familial Colorectal Neoplasia Collaborative Group

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (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 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.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
GENETIC	DNA stability analysis
GENETIC	gene rearrangement analysis

Timeline

• Start date: 1998-07-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2003-10-29
• Last updated: 2016-07-04

Locations

12 sites across 2 countries: United States, Canada