Familial Factors in the Development of Colon Cancer
N/A
70 Years
Both
Colorectal Cancer
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, Incorporated | Goldsboro, North Carolina 27534 |
