Genetic Study of Familial Factors in Patients With Colon Cancer

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), July 2008

First Received: March 6, 2003 Last Updated: February 13, 2009 History of Changes

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055848

Purpose

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.

Condition	Intervention
Colorectal Cancer	Genetic: cytogenetic analysis Genetic: gene mapping Genetic: microarray analysis

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	Familial Factors in the Development of Colon Cancer

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	600
Study Start Date:	December 2001

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.

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055848

Locations

United States, North Carolina
Wayne Memorial Hospital, Incorporated	Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD 919-580-0000

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Monica M. Bertagnolli, MD

Dana-Farber/Brigham and Women's Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000271314, CALGB-150008
Study First Received:	March 6, 2003
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00055848 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the colon
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases

Adenocarcinoma
Rectal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009