Gene Testing in Patients With Colon Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003571
First received: November 1, 1999
Last updated: April 24, 2010
Last verified: October 2007

November 1, 1999
April 24, 2010
August 1998
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Complete list of historical versions of study NCT00003571 on ClinicalTrials.gov Archive Site
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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
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Colorectal Cancer
  • Genetic: mutation analysis
  • Genetic: tumor replication error analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003571
CDR0000066637, CLB-9865
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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