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

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00003833
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 598

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	Up to 10 years

Trial Locations

Locations (59)

St. Mary's/Duluth Clinic Health System; 🇺🇸 Duluth, Minnesota, United States

Tom Baker Cancer Center - Calgary; 🇨🇦 Calgary, Alberta, Canada

Lethbridge Cancer Clinic; 🇨🇦 Lethbridge, Alberta, Canada

Nanaimo Cancer Clinic; 🇨🇦 Nanaimo, British Columbia, Canada

British Columbia Cancer Agency - Fraser Valley Cancer Centre; 🇨🇦 Surrey, British Columbia, Canada

Prostate Centre at Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

St. Paul's Hospital - Vancouver; 🇨🇦 Vancouver, British Columbia, Canada

G. Steinhoff Clinical Research; 🇨🇦 Victoria, British Columbia, Canada

Moncton Hospital; 🇨🇦 Moncton, New Brunswick, Canada

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