Clinical trial · Observational
Studying Tissue Samples From Patients With Stage II Colon Cancer Treated on Clinical Trial CLB-9581
Correlative Science Studies in Colon Cancer a Companion Study to CALGB 9581 and 89803
NCT00897429CI-TRIAL-00037168completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (laboratory biomarker analysis)
- description
- 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.
- interventionNames
- Procedure: laboratory biomarker analysis
Primary outcomes (11)
- measure
- Analyses of molecular models among patients who completed the diet and lifestyle questionnaire and who provided tumor blocks for analyses (B1)
- timeFrame
- Up to 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.