Biomarkers in Plasma Specimens From Patients Treated on Study CALGB-80303
RATIONALE: Studying plasma samples from patients with pancreatic cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research trial studies biomarkers in samples from patients with pancreatic cancer treated on study CALGB-80303.
Other: enzyme-linked immunosorbent assay
Other: laboratory biomarker analysis
|Official Title:||Validation of Circulating Biomarkers Using the Immunological Multiparameter Chip Technology (IMPACT) on Plasma Specimens Collected on CALGB 80303|
- Median OS/PFS (95% CI) estimated from Kaplan-Meier curves for patients with low and patients with high biomarker levels [ Designated as safety issue: No ]
- Stratified OS/PFS hazard ratio (HR) (95% CI) from the Cox model for patients with low and patients with high biomarker levels [ Designated as safety issue: No ]
- Stratified OS/PFS HR (95% CI) from Cox model by quartile of VEGF-A levels [ Designated as safety issue: No ]
- Number and percentage of responders and the stratified objective response (OR) from logistic regression for patients with high and low concentration of biomarker [ Designated as safety issue: No ]
- To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for overall survival (OS) in study BO17706 can be replicated in study CALGB-80303 using the same Immunological Multiparameter Chip Technology (IMPACT) assay.
- To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for progression-free survival (PFS), and other circulating biomarkers in study BO17706, can be replicated in study CALGB-80303 using the same IMPACT assay.
- To explore the relationship between efficacy and other biomarkers measured in the plasma samples.
OUTLINE: The samples required for this study are stored in the CALGB Pathology Coordinating Office at The Ohio State University from patients enrolled on protocol CALGB-80303. No additional samples are required from patients.
The following markers are analyzed in EDTA plasma samples using the Immunological MultiParameter Chip Technology (IMPACT) a Roche proprietary multiplex enzyme-linked immunosorbent assay (ELISA) platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3, IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664169
|Principal Investigator:||Herbert Pang, PhD||CALGB Statistical Office at Duke University Medical Center|