RATIONALE: Genetic studies may help in understanding the genetic processes that cause some types of cancer. PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer...
Date First Received: November 1, 1999
Last Updated: July 23, 2008
Verified by: National Cancer Institute (NCI), October 2002
Clinical Trial Phase: N/A | Start Date: February 1999
Overall Status: Completed
Brief Summary
Official Title: “The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer”
Condition Keyword(s):
Intervention(s):
RATIONALE: Genetic studies may help in understanding the genetic processes that cause some types of cancer.
PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer.
Study Type: Observational
Study Design: N/A
Detailed Clinical Trial Description
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.
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.
PROJECTED ACCRUAL: Approximately 480 patients will be accrued for this study.
Intervention(s) in this Clinical Trial
- Procedure: DNA stability analysis
- Procedure: gene mapping
Criteria for Participation in this Clinical Trial
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
PATIENT CHARACTERISTICS:
- Age
- Under 70
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 69 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: North Central Cancer Treatment Group
Overall Clinical Trial Officials and Contacts
Richard M. Goldberg, MD Study Chair Mayo Clinic
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00003833
Study ID Number: CDR0000066990
ClinicalTrials.gov Identifier: NCT00003833
Health Authority: United States: Federal Government
Clinical trial summary from the National Cancer Institute's PDQ® database
Clinical Trials Authorship and Review
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