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Genetic Study of Familial Factors in Patients With Colon Cancer

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ClinicalTrials.gov Identifier: NCT00055848
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : July 13, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Colorectal Cancer Genetic: cytogenetic analysis Genetic: gene mapping Genetic: microarray analysis

Detailed Description:


  • 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.

Study Design

Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Familial Factors in the Development of Colon Cancer
Study Start Date : December 2001
Primary Completion Date : October 2010
Study Completion Date : October 2010
Groups and Cohorts

Group/Cohort Intervention/treatment
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.

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

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.


  • 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.



  • 70 and under at diagnosis


  • No significant psychiatric illness that would preclude giving informed consent
  • No inflammatory bowel disease (in patient or sibling)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055848

United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Monica M. Bertagnolli, MD Dana-Farber/Brigham and Women's Cancer Center
More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00055848     History of Changes
Other Study ID Numbers: CALGB-150008
CDR0000271314 ( Registry Identifier: NCI Physician Data Query )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2015

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

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