Genetic Study of Familial Factors in Patients With Colon Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

March 6, 2003

Last Updated Date

February 13, 2009

Start Date ^ICMJE

December 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00055848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Genetic Study of Familial Factors in Patients With Colon Cancer

Official Title ^ICMJE

Familial Factors in the Development of Colon Cancer

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.

OUTLINE: This is a multicenter study.

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.

PROJECTED ACCRUAL: A total of 600 patients (300 sibling pairs) will be accrued for this study.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Gender

Both

Ages

up to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00055848

Responsible Party

Study ID Numbers ^ICMJE

CDR0000271314, CALGB-150008

Study Sponsor ^ICMJE

Cancer and Leukemia Group B

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Monica M. Bertagnolli, MD

Dana-Farber/Brigham and Women's Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP