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

NCT ID: NCT00003833

Last Updated: 2016-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

598 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-02-28

Study Completion Date

2006-08-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal and tumor tissue pairs

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.

DNA stability analysis

Intervention Type GENETIC

gene mapping

Intervention Type GENETIC

Interventions

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DNA stability analysis

Intervention Type GENETIC

gene mapping

Intervention Type GENETIC

Eligibility Criteria

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Inclusion 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

PATIENT CHARACTERISTICS:

Age

* Under 70
Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard M. Goldberg, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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St. Mary's/Duluth Clinic Health System

Duluth, Minnesota, United States

Site Status

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Site Status

Lethbridge Cancer Clinic

Lethbridge, Alberta, Canada

Site Status

Nanaimo Cancer Clinic

Nanaimo, British Columbia, Canada

Site Status

British Columbia Cancer Agency - Fraser Valley Cancer Centre

Surrey, British Columbia, Canada

Site Status

Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Site Status

St. Paul's Hospital - Vancouver

Vancouver, British Columbia, Canada

Site Status

G. Steinhoff Clinical Research

Victoria, British Columbia, Canada

Site Status

Moncton Hospital

Moncton, New Brunswick, Canada

Site Status

Doctor Leon Richard Oncology Centre

Moncton, New Brunswick, Canada

Site Status

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, Canada

Site Status

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Site Status

Cape Breton Cancer Centre

Sydney, Nova Scotia, Canada

Site Status

Royal Victoria Hospital, Barrie

Barrie, Ontario, Canada

Site Status

William Osler Health Centre

Brampton, Ontario, Canada

Site Status

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, Canada

Site Status

Hamilton and District Urology Association

Hamilton, Ontario, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Markham Stouffville Hospital

Markham, Ontario, Canada

Site Status

Trillium Health Centre

Mississauga, Ontario, Canada

Site Status

Credit Valley Hospital

Mississauga, Ontario, Canada

Site Status

York County Hospital

Newmarket, Ontario, Canada

Site Status

North York General Hospital, Ontario

North York, Ontario, Canada

Site Status

Male Health Centre/CMX Research Inc.

Oakville, Ontario, Canada

Site Status

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Site Status

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Site Status

Peterborough Oncology Clinic

Peterborough, Ontario, Canada

Site Status

Scarborough Hospital - General Site

Scarborough Village, Ontario, Canada

Site Status

Hotel Dieu Health Sciences Hospital - Niagara

St. Catharines, Ontario, Canada

Site Status

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, Canada

Site Status

Toronto East General Hospital

Toronto, Ontario, Canada

Site Status

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Site Status

St. Michael's Hospital - Toronto

Toronto, Ontario, Canada

Site Status

Mount Sinai Hospital - Toronto

Toronto, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Women's College Campus, Sunnybrook and Women's College Health Science Center

Toronto, Ontario, Canada

Site Status

Saint Joseph's Health Centre - Toronto

Toronto, Ontario, Canada

Site Status

Humber River Regional Hospital

Weston, Ontario, Canada

Site Status

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, Canada

Site Status

Queen Elizabeth Hospital, PEI

Charlottetown, Prince Edward Island, Canada

Site Status

CHUS-Hopital Fleurimont

Fleurimont, Quebec, Canada

Site Status

Hopital Charles Lemoyne

Greenfield Park, Quebec, Canada

Site Status

Centre Hospitalier Regional de Lanaudiere

Joliette, Quebec, Canada

Site Status

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status

McGill University

Montreal, Quebec, Canada

Site Status

Hopital Sainte Justine

Montreal, Quebec, Canada

Site Status

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Site Status

Kells Medical Research Group Inc.

Pointe-Claire, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, Canada

Site Status

Hopital du Saint-Sacrament, Quebec

Québec, Quebec, Canada

Site Status

Centre Hospitalier Regional de Rimouski

Rimouski, Quebec, Canada

Site Status

L'Hopital Laval

Ste-Foy, Quebec, Canada

Site Status

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

Lions Gate Hospital

North Vancouver, , Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CDR0000066990

Identifier Type: REGISTRY

Identifier Source: secondary_id

CAN-NCIC-CO9PATH

Identifier Type: -

Identifier Source: secondary_id

NCCTG-984654

Identifier Type: -

Identifier Source: org_study_id

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