Genetic Study of Familial Factors in Patients With Colon Cancer

Colorectal Cancer Clinical Trial

Official title:

Familial Factors in the Development of Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055848
• Other study ID #: CALGB-150008
• Secondary ID: CALGB-150008CDR0
• Status: Completed
• Phase: N/A
• First received: March 6, 2003
• Last updated: July 12, 2016
• Start date: December 2001
• Est. completion date: October 2010

Study information

• Verified date: July 2015
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Genetic:
• cytogenetic analysis

• gene mapping

• microarray analysis

Locations

Country	Name	City	State
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,