Full Text View
Tabular View
No Study Results Posted
Related Studies
Gene Testing in Patients With Colon Cancer
This study has been completed.
Study NCT00003571   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
August 1998
 
 
 
Complete list of historical versions of study NCT00003571 on ClinicalTrials.gov Archive Site
 
 
 
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.

OUTLINE: 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.

PROJECTED ACCRUAL: At least 300 specimens will be accrued for this study.

 
Observational
 
Colorectal Cancer
  • Genetic: mutation analysis
  • Genetic: tumor replication error analysis
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003571
 
CDR0000066637, CLB-9865
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Monica M. Bertagnolli, MD Dana-Farber/Brigham and Women's Cancer Center
National Cancer Institute (NCI)
October 2007

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