Gene Testing in Patients With Colon Cancer
Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial
4 other identifiers
observational
300
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 1998
Longer than P75 for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
July 15, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJuly 6, 2016
July 1, 2016
7.4 years
November 1, 1999
July 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease free survival
Up to 10 years
Secondary Outcomes (3)
overall survival
Up to 10 years
tumor replication error status
Up to 10 years
determine the prognostic and predictive values for response to this therapy
Up to 10 years
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients previously enrolled on CALGB-8896.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (44)
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996, United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009, United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021, United States
Mount Sinai Medical Center, NY
New York, New York, 10029, United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
Related Publications (4)
Goel A, Arnold CN, Niedzwiecki D, Carethers JM, Dowell JM, Wasserman L, Compton C, Mayer RJ, Bertagnolli MM, Boland CR. Frequent inactivation of PTEN by promoter hypermethylation in microsatellite instability-high sporadic colorectal cancers. Cancer Res. 2004 May 1;64(9):3014-21. doi: 10.1158/0008-5472.can-2401-2.
PMID: 15126336BACKGROUNDGoel A, Arnold CN, Niedzwiecki D, Chang DK, Ricciardiello L, Carethers JM, Dowell JM, Wasserman L, Compton C, Mayer RJ, Bertagnolli MM, Boland CR. Characterization of sporadic colon cancer by patterns of genomic instability. Cancer Res. 2003 Apr 1;63(7):1608-14.
PMID: 12670912BACKGROUNDArnold CN, Goel A, Compton C, Marcus V, Niedzwiecki D, Dowell JM, Wasserman L, Inoue T, Mayer RJ, Bertagnolli MM, Boland CR. Evaluation of microsatellite instability, hMLH1 expression and hMLH1 promoter hypermethylation in defining the MSI phenotype of colorectal cancer. Cancer Biol Ther. 2004 Jan;3(1):73-8. doi: 10.4161/cbt.3.1.590. Epub 2004 Jan 5.
PMID: 14726676RESULTGoel A, Arnold CN, Tassone P, Chang DK, Niedzwiecki D, Dowell JM, Wasserman L, Compton C, Mayer RJ, Bertagnolli MM, Boland CR. Epigenetic inactivation of RUNX3 in microsatellite unstable sporadic colon cancers. Int J Cancer. 2004 Dec 10;112(5):754-9. doi: 10.1002/ijc.20472.
PMID: 15386381RESULT
Biospecimen
Samples of tumor and normal tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Monica M. Bertagnolli, MD
Dana-Farber/Brigham and Women's Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
July 15, 2003
Study Start
August 1, 1998
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
July 6, 2016
Record last verified: 2016-07