Studying Tissue Samples From Patients With Stage II Colon Cancer Treated on Clinical Trial CLB-9581

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 9, 2009
Last updated: March 7, 2012
Last verified: September 2007

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.

PURPOSE: This laboratory study is looking at tissue samples from patients with stage II treated on clinical trial CLB-9581.

Condition Intervention
Colorectal Cancer
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: polyacrylamide gel electrophoresis
Genetic: polymerase chain reaction
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: diagnostic laboratory biomarker analysis
Other: immunohistochemistry staining method

Study Type: Observational
Official Title: Correlative Science Studies in Colon Cancer a Companion Study to CALGB 9581 and 89803

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Associate methylated and silenced DNA repair genes, MLH1, WRN, or MGMT, or CIMP colorectal cancers with the clinical endpoints of overall (OS) and disease-free survival (DFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DFS [ Designated as safety issue: No ]
  • Predictive value of other novel methylated genes indentified through methylation array studies [ Designated as safety issue: No ]
  • Correlate CIMP and methylated genes with other genetic alterations and tumor-specific characteristics [ Designated as safety issue: No ]
  • MRE11 status of the MSI tumors and correlate with response to the camptothecin-related compound irinotecan [ Designated as safety issue: No ]

Estimated Enrollment: 902
Study Start Date: July 2007
Detailed Description:



  • To assess the ability of a prognostic gene expression signature to stratify stage II colorectal cancer patients into those who will experience relapse within five years post surgery (high risk) and those who will experience five-year disease-free survival (low risk), without additional treatment.
  • To correlate the methylation status of the individual genes, MLH1, WRN, and MGMT with survival.
  • To correlate the CIMP status (CIMP vs nonCIMP) of the tumors with survival.
  • To correlate the expression status of the individual genes based on the immunostaining results with survival.
  • To correlate the expression of the functional groups of proteins in which survival is correlated with the expression of the MLH1 functional group (MLH1, PMS2, and MSH2), the WRN functional group (WRN, MRE11, and MLH1), and the MGMT functional group (MGMT, MYH, and OGG) with survival (the loss of expression of any member of each functional group will be scored as indicating loss of function of the functional group).
  • To correlate the mutation status of MRE11 in MSI colorectal cancers with disease-free survival and overall survival.


  • To define the association of CIMP and methylated genes with other genetic alterations and tumor-specific characteristics.

OUTLINE: This is a multicenter, companion study.

Tissue samples from patients are analyzed for K-ras mutations; COX-2, phospho-AKT, and VEGF overexpression; microvessel density; association of genomic instability with microsatellite instability and p53 mutations; and methylation status of MLH1, MGMT, and WRN and to identify prognostic biomarkers by LINE-1 hypomethylation, PIK3CA mutation, BRAF mutation, fatty acid sysnthase (FASN) expression, and vitamin D receptor (VDR) expression.Techniques used include immunohistochemistry, PCR, RT-PCR, and gel electrophoresis.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histopathological proof of adenocarcinoma of the colon meeting the following criteria:

    • Primary diagnosis of stage II colon cancer according to the AJCC/UICC T and M classification (T3M0 or T4M0 only)

      • Patients are not excluded based solely on M stage being unknown
    • No positive nodes
  • Surgery of the colon with curative intent only

    • No gross or microscopic evidence of residual disease; all margins, proximal, distal, and radial, must be negative
    • No pre-operative therapy of any kind administered within 1 year of surgery
    • No post-operative therapy administered, except protocol-related edrecolomab in the case of CALGB-9581 samples

      • Patients in the CALGB-9581 trial who received nonprotocol-related therapy (chemotherapy or radiotherapy) after diagnosis of cancer recurrence are eligible for the study
  • Must be registered on clinical trial CLB-9581


  • Not specified


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT00897429

Sponsors and Collaborators
Cancer and Leukemia Group B
Study Chair: Monica M. Bertagnolli, MD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00897429     History of Changes
Other Study ID Numbers: CDR0000559812, CALGB-150705-ICSC
Study First Received: May 9, 2009
Last Updated: March 7, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIA colon cancer
stage IIB colon cancer
stage IIC colon cancer processed this record on July 01, 2015