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Genetic Study of Allelic Imbalance of Chromosome 8p in Patients with Stage II or III Colon Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Genetic Study in Patients With Stage II or Stage III Colon Cancer

Basic Trial Information

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 Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Richard Goldberg, MD, Protocol chair(Contact information may not be current)
Ph: 507-266-0029
Email: goldberg.richard@mayo.edu

NCIC-Clinical Trials Group

Lois Shepherd, MD, Protocol chair
Ph: 613-533-6430
Email: lshepherd@ctg.queensu.ca

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

Trial Start Date		1999-02-19

Registered in ClinicalTrials.gov		NCT00003833

Date Submitted to PDQ		1999-03-25

Information Last Verified		2002-10-15

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.