Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

November 1, 1999
July 1, 2016
August 1998
January 2006   (final data collection date for primary outcome measure)
disease free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003571 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Gene Testing in Patients With Colon Cancer
Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Samples of tumor and normal tissue
Non-Probability Sample
Patients previously enrolled on CALGB-8896.
Colorectal Cancer
  • Genetic: mutation analysis
  • Genetic: tumor replication error analysis
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:
  • Genetic: mutation analysis
  • Genetic: tumor replication error analysis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
January 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003571
CALGB-9865, U10CA031946, CLB-9865, CDR0000066637
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Monica M. Bertagnolli, MD Dana-Farber/Brigham and Women's Cancer Center
Alliance for Clinical Trials in Oncology
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP