Genetic Study of Familial Factors in Patients With Colon Cancer

Familial Factors in the Development of Colon Cancer

RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.

PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Genetic: cytogenetic analysis; Genetic: microarray analysis; Genetic: gene mapping

Detailed Description

OBJECTIVES:

• Identify human colon neoplasia susceptibility genes in patients with colon cancer or adenomatous polyps.
• Correlate the inheritance of novel susceptibility alleles for adenomatous polyposis of the colon with colon neoplasia in these patients.
• Correlate colon neoplasia susceptibility with the presence of COX-2, sPLA2, and DNMT genes in these patients.
• Identify a novel gene that governs increased susceptibility to colon adenoma and cancer in the genome of these patients.

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Memorial Hospital, Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with colon cancer or polyps age 70 or under. Specifically, patients previously enrolled on CLB-9581, CLB-89803 and CLB-80001.

Description

DISEASE CHARACTERISTICS:

• Diagnosis of colon cancer or polyps at age 70 or under
• Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under
• No history of familial adenomatous polyposis syndrome
• No hereditary nonpolyposis colon cancer, according to Amsterdam criteria
• No known I1370K adenomatous polyposis of the colon susceptibility variant

• Enrolled on 1 of the following clinical trials:

  • CLB-9581
  • CLB-89803
  • CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible.

PATIENT CHARACTERISTICS:

Age

• 70 and under at diagnosis

Other

• No significant psychiatric illness that would preclude giving informed consent
• No inflammatory bowel disease (in patient or sibling)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Group 1; Patients donate blood samples for analysis of colorectal susceptibility genes. Patients also complete a questionnaire regarding family cancer history. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute. Participants do not receive the results of the genetic testing, and the results do not influence the type or duration of treatment.

Genetic: cytogenetic analysis; Genetic: microarray analysis; Genetic: gene mapping

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Monica M. Bertagnolli, MD, Dana-Farber/Brigham and Women's Cancer Center

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: March 6, 2003
• First Submitted That Met QC Criteria: March 6, 2003
• First Posted (Estimate): March 7, 2003

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: stage IV colon cancer; adenocarcinoma of the colon; stage III colon cancer; stage II colon cancer; stage I colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: CALGB-150008; CDR0000271314 (Registry Identifier: NCI Physician Data Query)