Gene Testing in Patients With Colon Cancer
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.
Genetic: mutation analysis
Genetic: tumor replication error analysis
|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|
- disease free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||August 1998|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
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|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003571
Show 44 Study Locations
|Study Chair:||Monica M. Bertagnolli, MD||Dana-Farber/Brigham and Women's Cancer Center|