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

Colorectal Cancer Clinical Trial

Official title:

The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003833
• Other study ID #: NCCTG-984654
• Secondary ID: CDR0000066990CAN
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: July 12, 2016
• Start date: February 1999
• Est. completion date: August 2006

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 69 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Genetic:
• DNA stability analysis

• gene mapping

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital, Barrie	Barrie	Ontario
Canada	William Osler Health Centre	Brampton	Ontario
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Queen Elizabeth Hospital, PEI	Charlottetown	Prince Edward Island
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Hamilton and District Urology Association	Hamilton	Ontario
Canada	Centre Hospitalier Regional de Lanaudiere	Joliette	Quebec
Canada	Lethbridge Cancer Clinic	Lethbridge	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	Markham Stouffville Hospital	Markham	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	Trillium Health Centre	Mississauga	Ontario
Canada	Doctor Leon Richard Oncology Centre	Moncton	New Brunswick
Canada	Moncton Hospital	Moncton	New Brunswick
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Hopital Du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Hopital Sainte Justine	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Nanaimo Cancer Clinic	Nanaimo	British Columbia
Canada	York County Hospital	Newmarket	Ontario
Canada	Lions Gate Hospital	North Vancouver
Canada	North York General Hospital, Ontario	North York	Ontario
Canada	Male Health Centre/CMX Research Inc.	Oakville	Ontario
Canada	Lakeridge Health Oshawa	Oshawa	Ontario
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Peterborough Oncology Clinic	Peterborough	Ontario
Canada	Kells Medical Research Group Inc.	Pointe Claire	Quebec
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Hopital du Saint-Sacrament, Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Centre Hospitalier Regional de Rimouski	Rimouski	Quebec
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Scarborough Hospital - General Site	Scarborough	Ontario
Canada	Hotel Dieu Health Sciences Hospital - Niagara	St. Catharines	Ontario
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	L'Hopital Laval	Ste-Foy	Quebec
Canada	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario
Canada	British Columbia Cancer Agency - Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Cape Breton Cancer Centre	Sydney	Nova Scotia
Canada	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario
Canada	Mount Sinai Hospital - Toronto	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Saint Joseph's Health Centre - Toronto	Toronto	Ontario
Canada	St. Michael's Hospital - Toronto	Toronto	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Women's College Campus, Sunnybrook and Women's College Health Science Center	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Canada	Prostate Centre at Vancouver General Hospital	Vancouver	British Columbia
Canada	St. Paul's Hospital - Vancouver	Vancouver	British Columbia
Canada	G. Steinhoff Clinical Research	Victoria	British Columbia
Canada	Humber River Regional Hospital	Weston	Ontario
Canada	Cancer Care Ontario - Windsor Regional Cancer Centre	Windsor	Ontario
United States	St. Mary's/Duluth Clinic Health System	Duluth	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI), NCIC Clinical Trials Group

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		Up to 10 years	No