Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Genetics | Completed | 70 and under at diagnosis | NCI | CALGB-150008 NCT00055848 |
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.
Entry 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.]
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
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)
Expected Enrollment
600A total of 600 patients (300 sibling pairs) will be accrued for this study.
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.
Trial Lead Organizations
Cancer and Leukemia Group B
 | | | |
| Monica Bertagnolli, MD, Protocol chair | |
| |
| |||
Related Information
PDQ® clinical trial CDR0000065473
PDQ® clinical trial CLB-89803
| Registry Information | ||
| ||
| Official Title | Familial Factors in the Development of Colon Cancer | |
| ||
| Trial Start Date | 2001-12-15 | |
| ||
| Registered in ClinicalTrials.gov | NCT00055848 | |
| ||
| Date Submitted to PDQ | 2003-01-17 | |
| ||
| Information Last Verified | 2008-07-17 | |
| ||
| NCI Grant/Contract Number | U10-CA31946 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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