Gene Testing in Patients With Colon Cancer

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Colorectal Cancer

Treatments: Genetic: mutation analysis; Genetic: tumor replication error analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00003571

U10CA031946 (U.S. NIH Grant/Contract)

CALGB-9865

CLB-9865

CDR0000066637 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

300 participants in 1 patient group

Samples of tumor and normal tissue

Description:

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.

Treatment:

Genetic: tumor replication error analysis

Genetic: mutation analysis