Gene Testing in Patients With Colon Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003571
First received: November 1, 1999
Last updated: July 3, 2015
Last verified: July 2015
  Purpose

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 Intervention
Colorectal Cancer
Genetic: mutation analysis
Genetic: tumor replication error analysis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • disease free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

Samples of tumor and normal tissue


Enrollment: 300
Study Start Date: August 1998
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed 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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients previously enrolled on CALGB-8896.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003571

  Show 44 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Monica M. Bertagnolli, MD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003571     History of Changes
Other Study ID Numbers: CALGB-9865, U10CA031946, CLB-9865, CDR0000066637
Study First Received: November 1, 1999
Last Updated: July 3, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage III colon cancer
adenocarcinoma of the colon

ClinicalTrials.gov processed this record on July 30, 2015