Gene Testing in Patients With Colon Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003571|
Recruitment Status : Completed
First Posted : July 15, 2003
Last Update Posted : July 6, 2016
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 or disease||Intervention/treatment|
|Colorectal Cancer||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.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Tumor Replication Error (RER) Status and Outcome in a Colon Cancer Adjuvant Chemotherapy Trial|
|Study Start Date :||August 1998|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
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|
- disease free survival [ Time Frame: Up to 10 years ]
- overall survival [ Time Frame: Up to 10 years ]
- tumor replication error status [ Time Frame: Up to 10 years ]
- determine the prognostic and predictive values for response to this therapy [ Time Frame: Up to 10 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003571
Show 44 Study Locations
|Study Chair:||Monica M. Bertagnolli, MD||Dana-Farber/Brigham and Women's Cancer Center|