Genetic Study of Familial Factors in Patients With Colon Cancer

NCT ID: NCT00055848

Last Updated: 2016-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-12-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

cytogenetic analysis

Intervention Type GENETIC

gene mapping

Intervention Type GENETIC

microarray analysis

Intervention Type GENETIC

Interventions

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cytogenetic analysis

Intervention Type GENETIC

gene mapping

Intervention Type GENETIC

microarray analysis

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

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)
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monica M. Bertagnolli, MD

Role: STUDY_CHAIR

Dana-Farber/Brigham and Women's Cancer Center

Locations

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Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CALGB-150008

Identifier Type: -

Identifier Source: secondary_id

CDR0000271314

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-150008

Identifier Type: -

Identifier Source: org_study_id

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