Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
Genetic Study in Patients With Stage II or Stage III Colon Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Genetics | Completed | Under 70 | NCI | NCCTG-984654 CAN-NCIC-CO9PATH, NCT00003833, NCCTG-98-46-54, CO9PATH |
Objectives
- Determine the adverse prognostic significance of 8p allelic imbalance (AI) in patients with colon cancer.
- Determine if patient prognosis is dependent on the region of 8p AI.
- Perform fine mapping studies to further localize the putative tumor suppressor gene(s) on 8p.
- Perform multicolor FISH to examine the role that 8p loss and 8q gain play in the prognosis of patients whose tumors exhibit 8p AI.
Entry Criteria
Disease Characteristics:
- Diagnosis of resectable stage II or III adenocarcinoma of the colon
- Participated in NCCTG-914653
- DNA extracted from both normal and tumor tissue
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Patient Characteristics:
Age
- Under 70
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Expected Enrollment
Approximately 480 patients will be accrued for this study.
Outline
Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.
Trial Lead Organizations
North Central Cancer Treatment Group
 | | | ||
| Richard Goldberg, MD, Protocol chair(Contact information may not be current) | |
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NCIC-Clinical Trials Group
| | | ||
| Lois Shepherd, MD, Protocol chair | |
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Related Information
PDQ® clinical trial NCCTG-914653
| Registry Information | ||
| ||
| Official Title | The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients with Colorectal Cancer | |
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| Trial Start Date | 1999-02-19 | |
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| Registered in ClinicalTrials.gov | NCT00003833 | |
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| Date Submitted to PDQ | 1999-03-25 | |
| ||
| Information Last Verified | 2002-10-15 | |
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| NCI Grant/Contract Number | 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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