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

Completed

• Conditions: Colorectal Cancer
• Interventions: Genetic: DNA stability analysis; Genetic: gene rearrangement analysis

• Registration Number: NCT00003648
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Study Timeline

• Study Start: 1998-07
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-10-28
• Study First Posted: 2003-10-29
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	gene rearrangement analysis	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.
Group 1	DNA stability analysis	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.

Primary Outcome Measures

Name	Time	Method
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	Up to 5 years

Trial Locations

Locations (12)

CCOP - Cedar Rapids Oncology Project; 🇺🇸 Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium; 🇺🇸 Omaha, Nebraska, United States

Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium; 🇺🇸 Sioux Falls, South Dakota, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

Siouxland Hematology-Oncology; 🇺🇸 Sioux City, Iowa, United States

CentraCare Clinic; 🇺🇸 Saint Cloud, Minnesota, United States

Allan Blair Cancer Centre; 🇨🇦 Regina, Saskatchewan, Canada

Medcenter One Health System; 🇺🇸 Bismarck, North Dakota, United States

CCOP - Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States