MedPath

Gene Testing in Patients With Colon Cancer

Completed
Conditions
Colorectal Cancer
Interventions
Genetic: mutation analysis
Genetic: tumor replication error analysis
Registration Number
NCT00003571
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Samples of tumor and normal tissuemutation analysisSamples 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.
Samples of tumor and normal tissuetumor replication error analysisSamples 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.
Primary Outcome Measures
NameTimeMethod
disease free survivalUp to 10 years
Secondary Outcome Measures
NameTimeMethod
overall survivalUp to 10 years
tumor replication error statusUp to 10 years
determine the prognostic and predictive values for response to this therapyUp to 10 years

Trial Locations

Locations (44)

CCOP - Christiana Care Health Services

🇺🇸

Wilmington, Delaware, United States

University of California San Diego Cancer Center

🇺🇸

La Jolla, California, United States

Lombardi Cancer Center

🇺🇸

Washington, District of Columbia, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital)

🇺🇸

Chicago, Illinois, United States

Veterans Affairs Medical Center - Memphis

🇺🇸

Memphis, Tennessee, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

Veterans Affairs Medical Center - Buffalo

🇺🇸

Buffalo, New York, United States

Roswell Park Cancer Institute

🇺🇸

Buffalo, New York, United States

Norris Cotton Cancer Center

🇺🇸

Lebanon, New Hampshire, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

🇺🇸

Baltimore, Maryland, United States

Veterans Affairs Medical Center - Togus

🇺🇸

Togus, Maine, United States

CCOP - Mount Sinai Medical Center

🇺🇸

Miami Beach, Florida, United States

University of Chicago Cancer Research Center

🇺🇸

Chicago, Illinois, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial)

🇺🇸

Columbia, Missouri, United States

Veterans Affairs Medical Center - Syracuse

🇺🇸

Syracuse, New York, United States

New York Presbyterian Hospital - Cornell Campus

🇺🇸

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

Dana-Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

CCOP - North Shore University Hospital

🇺🇸

Manhasset, New York, United States

Holden Comprehensive Cancer Center at The University of Iowa

🇺🇸

Iowa City, Iowa, United States

Barnes-Jewish Hospital

🇺🇸

Saint Louis, Missouri, United States

University of Massachusetts Memorial Medical Center

🇺🇸

Worcester, Massachusetts, United States

Ellis Fischel Cancer Center - Columbia

🇺🇸

Columbia, Missouri, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

🇺🇸

Syracuse, New York, United States

Mount Sinai Medical Center, NY

🇺🇸

New York, New York, United States

Lineberger Comprehensive Cancer Center, UNC

🇺🇸

Chapel Hill, North Carolina, United States

CCOP - Southeast Cancer Control Consortium

🇺🇸

Winston-Salem, North Carolina, United States

Schneider Children's Hospital at North Shore

🇺🇸

Manhasset, New York, United States

State University of New York - Upstate Medical University

🇺🇸

Syracuse, New York, United States

Comprehensive Cancer Center at Wake Forest University

🇺🇸

Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital - Ohio State University

🇺🇸

Columbus, Ohio, United States

University of Tennessee, Memphis Cancer Center

🇺🇸

Memphis, Tennessee, United States

Veterans Affairs Medical Center - White River Junction

🇺🇸

White River Junction, Vermont, United States

MBCCOP - Massey Cancer Center

🇺🇸

Richmond, Virginia, United States

CCOP - Southern Nevada Cancer Research Foundation

🇺🇸

Las Vegas, Nevada, United States

Veterans Affairs Medical Center - Minneapolis

🇺🇸

Minneapolis, Minnesota, United States

Veterans Affairs Medical Center - Durham

🇺🇸

Durham, North Carolina, United States

Duke Comprehensive Cancer Center

🇺🇸

Durham, North Carolina, United States

Veterans Affairs Medical Center - Birmingham

🇺🇸

Birmingham, Alabama, United States

Veterans Affairs Medical Center - San Francisco

🇺🇸

San Francisco, California, United States

UCSF Cancer Center and Cancer Research Institute

🇺🇸

San Francisco, California, United States

University of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

Veterans Affairs Medical Center - Richmond

🇺🇸

Richmond, Virginia, United States

Rhode Island Hospital

🇺🇸

Providence, Rhode Island, United States

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