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

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	Procedure: cytogenetic analysis Procedure: gene expression profiling Procedure: gene mapping

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

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

Study ID Numbers:	CDR0000271314, CALGB-150008
First Received:	March 6, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00055848
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

Neoplasms by Site

ClinicalTrials.gov processed this record on October 15, 2008

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