Genetic Study of Familial Factors in Patients With Colon Cancer

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Colorectal Cancer

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00055848

CALGB-150008

CDR0000271314 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

600 participants in 1 patient group

Group 1

Description:

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.

Treatment:

Genetic: gene mapping

Genetic: cytogenetic analysis

Genetic: microarray analysis