Genetic Study of Familial Factors in Patients With Colon Cancer

Completed

• Conditions: Colorectal Cancer
• Interventions: Genetic: cytogenetic analysis; Genetic: gene mapping; Genetic: microarray analysis

• Registration Number: NCT00055848
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

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 Timeline

• Study Start: 2001-12
• Study First Submitted: 2003-03-06
• Study First Submitted QC: 2003-03-06
• Study First Posted: 2003-03-07
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2015-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 mapping	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.
Group 1	cytogenetic analysis	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.
Group 1	microarray analysis	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.

Trial Locations

Locations (1)

Wayne Memorial Hospital, Incorporated; 🇺🇸 Goldsboro, North Carolina, United States