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Familial Factors in the Development of Colon Cancer


N/A
N/A
70 Years
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

Familial Factors in the Development of Colon Cancer


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Monica M. Bertagnolli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000271314

NCT ID:

NCT00055848

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • stage I colon cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage IV colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534