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Genetic Study of Familial Factors in Patients With Colon Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00055848
First received: March 6, 2003
Last updated: November 9, 2010
Last verified: July 2008
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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
Goldsboro, North Carolina, United States, 27534
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

ClinicalTrials.gov Identifier: NCT00055848     History of Changes
Other Study ID Numbers: CDR0000271314, CALGB-150008
Study First Received: March 6, 2003
Last Updated: November 9, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 22, 2013