Clinical Trials (PDQ®) - National Cancer Institute

Page Options

Clinical Trial Questions?

Get Help:

	Quick Links


	Help Using the NCI Clinical Trials Search Form Educational Materials About Clinical Trials About NCI's Cancer Clinical Trials Registry Dictionary of Cancer Terms NCI Drug Dictionary

Genetic Study of Familial Factors in Patients With Colon Cancer

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Genetics Active 70 and under at diagnosis NCI CALGB-150008
NCT00055848

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.

Entry 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.]

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

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)

Expected Enrollment

600

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

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Monica M. Bertagnolli, MD, Protocol chair
Ph: 617-732-8910; 800-638-6294

Trial Sites

U.S.A.

North Carolina

Goldsboro

Wayne Memorial Hospital, Incorporated

James Atkins, MD
Ph: 919-580-0000

Related Information

PDQ® clinical trial CLB-9581
PDQ® clinical trial CLB-89803

Registry Information

Official Title		Familial Factors in the Development of Colon Cancer

Trial Start Date		2001-12-15

Registered in ClinicalTrials.gov		NCT00055848

Date Submitted to PDQ		2003-01-17

Information Last Verified		2008-07-17

NCI Grant/Contract Number		U10-CA31946

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.