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

NCT00897429 | Completed

• 4 other identifiers: CALGB-150705CDR0000559812NCI-2009-00452U10CA180821
• Study Type: observational
• Target: 2,059
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

stage IIA colon cancer; stage IIB colon cancer; stage IIC colon cancer

Outcome Measures

Primary Outcomes (11)

• Analyses of molecular models among patients who completed the diet and lifestyle questionnaire and who provided tumor blocks for analyses (B1)

  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.

  Up to 5 years

• 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)

  4 years

• Influence of energy balance on tumor with specific molecular features (B1)

  Up to 5 years

• Influence of medications on tumors with specific molecular features (B1)

  Up to 5 years

• Detection of clones associated with overall survival (OS) (B2)

  Proper adjustment for multiplicity must be applied.

  Up to 5 years

• Recurrence-free interval (RFI) (B3)

  Will use the Kaplan Meier product-limit estimator.

  up to 5 years

• Clinical validation of the GHI 12-gene recurrence score (B4)

  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.

  Up to 5 years

• Clinical validation of the 15-gene second-generation recurrence score (B4)

  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.

  Up to 5 years

• Determination of whether the methylated and silenced DNA repair genes, MLH1, WRN, or MGMT, or CIMP colorectal cancers are associated with OS (B5)

  Up to 5 years

• Expression of newly identified prognostic biomarkers (LINE-1, PIK3CA, BRAF, FASN and VDR) on OS (B6)

  Interaction hazard ratios and the Cox model will be used.

  Up to 5 years

• Cancer-specific mortality (B6)

  Up to 5 years

Secondary Outcomes (4)

• Detection of clones associated with disease-free survival (DFS) (B2)

  Up to 5 years

• Determination of whether the methylated and silenced DNA repair genes, MLH1, WRN, or MGMT, or CIMP colorectal cancers are associated with DFS (B5)studies

  Up to 5 years

• MRE11 status of MSI tumors genetic alterations and tumor-specific characteristics

  Up to 5 years

• Evaluation of up to 768 new genes for their relationship with colon cancer recurrence (B4

  Up to 5 years

Study Arms (1)

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

Interventions

laboratory biomarker analysis PROCEDURE

Correlative studies

Ancillary-Correlative (laboratory biomarker analysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colon cancer registered to CALGB 9581 or 89803

You may qualify if:

• 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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Monica Bertagnolli, MD

  Brigham and Women's Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: July 1, 2007
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

US (1)