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

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

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Genetic: DNA stability analysis; Genetic: gene mapping

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 Type: Observational
• Enrollment (Actual): 598

Contacts and Locations

Study Locations

• Canada
  • North Vancouver, Canada, V7L 2P9
    • Lions Gate Hospital
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center - Calgary
    • Lethbridge, Alberta, Canada, T1J 1W5
      • Lethbridge Cancer Clinic
  • British Columbia
    • Nanaimo, British Columbia, Canada, V9S 2B7
      • Nanaimo Cancer Clinic
    • Surrey, British Columbia, Canada, V3V 1Z2
      • British Columbia Cancer Agency - Fraser Valley Cancer Centre
    • Vancouver, British Columbia, Canada, V5Z 3J5
      • Prostate Centre at Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital - Vancouver
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency
    • Victoria, British Columbia, Canada, V8V 3N1
      • G. Steinhoff Clinical Research
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6ZB
      • Moncton Hospital
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Doctor Leon Richard Oncology Centre
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Newfoundland and Labrador
    • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
      • Newfoundland Cancer Treatment and Research Foundation
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Cancer Centre
    • Sydney, Nova Scotia, Canada, B1P 1P3
      • Cape Breton Cancer Centre
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Hospital, Barrie
    • Brampton, Ontario, Canada, L6W 2Z8
      • William Osler Health Centre
    • Hamilton, Ontario, Canada, L8N 1T8
      • Hamilton And District Urology Association
    • London, Ontario, Canada, N6A 4G5
      • London Health Sciences Centre
    • Markham, Ontario, Canada, L3P 7T3
      • Markham Stouffville Hospital
    • Mississauga, Ontario, Canada, L5B 1B8
      • Trillium Health Centre
    • Mississauga, Ontario, Canada, L5M 2N1
      • Credit Valley Hospital
    • Newmarket, Ontario, Canada, L3Y 2P9
      • York County Hospital
    • North York, Ontario, Canada, M2K 1E1
      • North York General Hospital, Ontario
    • Oakville, Ontario, Canada, L6H 3PI
      • Male Health Centre/CMX Research Inc.
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Oshawa
    • Ottawa, Ontario, Canada, K1H 1C4
      • Ottawa Regional Cancer Centre
    • Peterborough, Ontario, Canada, K9H 7B6
      • Peterborough Oncology Clinic
    • Scarborough, Ontario, Canada, M1P 2V5
      • Scarborough Hospital - General Site
    • St. Catharines, Ontario, Canada, L2R 5K3
      • Hotel Dieu Health Sciences Hospital - Niagara
    • Sudbury, Ontario, Canada, P3E 5J1
      • Northeastern Ontario Regional Cancer Centre, Sudbury
    • Thunder Bay, Ontario, Canada, P7A 7T1
      • Northwestern Ontario Regional Cancer Centre, Thunder Bay
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
    • Toronto, Ontario, Canada, M4C 3E7
      • Toronto East General Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Regional Cancer Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital - Toronto
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital - Toronto
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
    • Toronto, Ontario, Canada, M5S 1B6
      • Women's College Campus, Sunnybrook and Women's College Health Science Center
    • Toronto, Ontario, Canada, M6R 1B5
      • Saint Joseph's Health Centre - Toronto
    • Weston, Ontario, Canada, M9N 1N8
      • Humber River Regional Hospital
    • Windsor, Ontario, Canada, N8W 2X3
      • Cancer Care Ontario - Windsor Regional Cancer Centre
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 8T5
      • Queen Elizabeth Hospital, PEI
  • Quebec
    • Fleurimont, Quebec, Canada, J1H 5N4
      • CHUS-Hopital Fleurimont
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hopital Charles LeMoyne
    • Joliette, Quebec, Canada, J6E 6J2
      • Centre Hospitalier Régional de Lanaudière
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University
    • Montreal, Quebec, Canada, H1T 2M4
      • Maisonneuve-Rosemont Hospital
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital du Sacre-Coeur de Montreal
    • Montreal, Quebec, Canada, H3T 1C5
      • Hopital Sainte Justine
    • Montreal, Quebec, Canada, (P.Q.) H2X 3J4
      • Centre Hospitalier de l'Université de Montréal
    • Pointe Claire, Quebec, Canada, H9R 4S3
      • Kells Medical Research Group Inc.
    • Quebec City, Quebec, Canada, G1R 2J6
      • Centre Hospitalier Universitaire de Quebec
    • Quebec City, Quebec, Canada, G1S 4L8
      • Hopital du Saint-Sacrament, Quebec
    • Rimouski, Quebec, Canada, G5L 5T1
      • Centre Hospitalier Regional De Rimouski
    • Ste-Foy, Quebec, Canada, G1V 4G5
      • L'Hopital Laval
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• United States
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • St. Mary's/Duluth Clinic Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 69 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced colon cancer previously participating in NCCTG-914653.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Genetic: DNA stability analysis; Genetic: gene mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	Up to 10 years

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI); NCIC Clinical Trials Group
• Investigators: Study Chair: Richard M. Goldberg, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 1999
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: adenocarcinoma of the colon; stage III colon cancer; stage II colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NCCTG-984654; CDR0000066990 (Registry Identifier: PDQ (Physician Data Query)); CAN-NCIC-CO9PATH