Gene Testing in Patients With Colon Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003571
First received: November 1, 1999
Last updated: July 1, 2016
Last verified: July 2016
  Purpose

RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer.

PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon cancer.


Condition Intervention
Colorectal Cancer
Genetic: mutation analysis
Genetic: tumor replication error analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • disease free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • tumor replication error status [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • determine the prognostic and predictive values for response to this therapy [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Samples of tumor and normal tissue

Enrollment: 300
Study Start Date: August 1998
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Samples of tumor and normal tissue
Samples of tumor and normal tissue are obtained from CALGB 8896 patients. The samples are tested for somatic mutations and tumor replication error (RER) tumor status. Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
Genetic: mutation analysis Genetic: tumor replication error analysis

Detailed Description:

OBJECTIVES:

  • Determine the relationship between disease free survival, overall survival, and tumor replication error status for patients who have received adjuvant chemotherapy for colon cancer on CALGB protocol 8896.
  • Determine the prognostic and predictive values for response to this therapy in these patients.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously enrolled on CALGB-8896.
Criteria

DISEASE CHARACTERISTICS:

  • Patients who received chemotherapy for colon cancer as part of CALGB protocol 8896
  • Underwent an initial resection for adenocarcinoma of the colon and were determined to have a high risk of tumor recurrence based upon nodal disease or local extension of tumor with obstruction or perforation due to tumor
  • Surgical specimen blocks available, including tumor tissue and normal tissue
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003571

  Hide Study Locations
Locations
United States, Alabama
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States, 35233-1996
United States, California
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
United States, Iowa
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Maine
Veterans Affairs Medical Center - Togus
Togus, Maine, United States, 04330
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Schneider Children's Hospital at North Shore
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States, 38104
United States, Vermont
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Monica M. Bertagnolli, MD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003571     History of Changes
Other Study ID Numbers: CALGB-9865  U10CA031946  CLB-9865  CDR0000066637 
Study First Received: November 1, 1999
Last Updated: July 1, 2016
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage III colon cancer
adenocarcinoma of the colon

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 21, 2016