Genetic Study of Familial Factors in Patients With Colon Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00055848
First received: March 6, 2003
Last updated: July 9, 2015
Last verified: July 2015
  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
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Familial Factors in the Development of Colon Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Enrollment: 600
Study Start Date: December 2001
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1

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.

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

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
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with colon cancer or polyps age 70 or under. Specifically, patients previously enrolled on CLB-9581, CLB-89803 and CLB-80001.

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

Other

  • No significant psychiatric illness that would preclude giving informed consent
  • No inflammatory bowel disease (in patient or sibling)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Monica M. Bertagnolli, MD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00055848     History of Changes
Other Study ID Numbers: CALGB-150008, CALGB-150008, CDR0000271314
Study First Received: March 6, 2003
Last Updated: July 9, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the colon
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer

ClinicalTrials.gov processed this record on July 30, 2015