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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00897429
First received: May 9, 2009
Last updated: July 23, 2015
Last verified: July 2015
  Purpose

This research trial studies tissue samples from patients with stage II colon cancer treated on Cancer and Leukemia Group B (CALGB)-9581 or CALGB-90903. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.


Condition Intervention
Colorectal Cancer
Procedure: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Analyses of molecular models among patients who completed the diet and lifestyle questionnaire and who provided tumor blocks for analyses (B1) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Using stratified analyses, effect modification by molecular alterations will be assessed. To maintain statistical power, body mass index and physical activity will be categorized into tertiles for the analyses of interactions with tumor molecular alterations. To assess whether the relative effect of an exposure differs according to the presence of the molecular alteration, tests for statistical interaction will be performed by entering into the model the cross-product term of the molecular alteration (as an indicator variable) and the other risk factor for cancer recurrence.

  • Proportion of patients who are cancer recurrence-free and alive at 4 years, approximating 4-year disease-free survival for the cohort to be 65% (B1) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Influence of energy balance on tumor with specific molecular features (B1) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Influence of medications on tumors with specific molecular features (B1) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Detection of clones associated with overall survival (OS) (B2) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Proper adjustment for multiplicity must be applied.

  • Recurrence-free interval (RFI) (B3) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Will use the Kaplan Meier product-limit estimator.

  • Clinical validation of the GHI 12-gene recurrence score (B4) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Weighted Cox proportional hazards regression models will be fit and Wald-type test statistics for the model parameters will be constructed using weighted partial likelihood estimates and robust variance estimates.

  • Clinical validation of the 15-gene second-generation recurrence score (B4) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Weighted Cox proportional hazards regression models will be fit and Wald-type test statistics for the model parameters will be constructed using weighted partial likelihood estimates and robust variance estimates.

  • Determination of whether the methylated and silenced DNA repair genes, MLH1, WRN, or MGMT, or CIMP colorectal cancers are associated with OS (B5) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Expression of newly identified prognostic biomarkers (LINE-1, PIK3CA, BRAF, FASN and VDR) on OS (B6) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Interaction hazard ratios and the Cox model will be used.

  • Cancer-specific mortality (B6) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detection of clones associated with disease-free survival (DFS) (B2) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Proper adjustment for multiplicity must be applied.

  • Determination of whether the methylated and silenced DNA repair genes, MLH1, WRN, or MGMT, or CIMP colorectal cancers are associated with DFS (B5)studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • MRE11 status of MSI tumors genetic alterations and tumor-specific characteristics [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    It is also planned to establish whether this correlates with response to the camptothecin-related compound irinotecan hydrochloride.

  • Evaluation of up to 768 new genes for their relationship with colon cancer recurrence (B4 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue


Estimated Enrollment: 902
Study Start Date: July 2007
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative (laboratory biomarker analysis)
Previously collected tissue samples 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, FASN expression, and VDR expression via immunohistochemistry, PCR, RT-PCR, and microarray.
Procedure: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with colon cancer registered to CALGB 9581 or 89803

Criteria

Inclusion Criteria:

  • Registration to CALGB 9581 or 89803
  • Samples present within the CALGB Pathology Coordinating Office (PCO) or at the institutions providing treatment that are sufficient to meet study aims
  • Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
  • CALGB does not require that a separate consent form be signed for this study:

    • The subject population to be studied in this protocol includes patients selected from either of the following CALGB treatment protocols: CALGB 9581 or 89803; all such patients have signed (or will sign) a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into those trials
    • All samples to be studied are obtained and stored as part of the patient's respective treatment trial; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
    • There should be no physical, psychological, social, or legal risks associated with this study; no invasive procedures are recommended or requested
    • All appropriate and necessary procedures will be utilized to maintain confidentiality; all patients who have had samples submitted for analysis will have their CALGB study number used to identify specimens
    • This study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated; it is likely, however, that the information gained will substantially help similar patients in the future
  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: NCT00897429

Contacts
Contact: Monica M. Bertagnolli, MD 617-732-8910

Locations
United States, Massachusetts
Alliance for Clinical Trials in Oncology Recruiting
Boston, Massachusetts, United States, 02115
Contact: Monica M. bertagnolli, MD    000-000-0000      
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:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00897429     History of Changes
Other Study ID Numbers: CALGB-150705, CDR0000559812, NCI-2009-00452, U10CA180821
Study First Received: May 9, 2009
Last Updated: July 23, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IIA colon cancer
stage IIB colon cancer
stage IIC colon cancer

ClinicalTrials.gov processed this record on July 27, 2015