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Biomarkers in Plasma Specimens From Patients Treated on Study CALGB-80303

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01664169
First received: August 10, 2012
Last updated: July 11, 2016
Last verified: July 2016

August 10, 2012
July 11, 2016
August 2012
January 2100   (final data collection date for primary outcome measure)
  • Overall survival [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Number and percentage of responder [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT01664169 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Biomarkers in Plasma Specimens From Patients Treated on Study CALGB-80303
Validation of Circulating Biomarkers Using the Immunological Multiparameter Chip Technology (IMPACT) on Plasma Specimens Collected on 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.

OBJECTIVES:

  • 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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
The following markers are analyzed in EDTA plasma samples using the IMPACT a Roche proprietary multiplex ELISA platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3, IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.
Non-Probability Sample
Patients diagnosed with pancreatic cancer and previously enrolled on CALGB-80303.
Pancreatic Cancer
Other: laboratory biomarker analysis
Single group

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 IMPACT a Roche proprietary multiplex ELISA platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3, IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.

Intervention: Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
307
Not Provided
January 2100   (final data collection date for primary outcome measure)

Patients must have been registered to CALGB-80303

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Locally advanced or metastatic disease
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01664169
A151201, CDR0000738204, NCI-2012-01994
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Principal Investigator: Herbert Pang, PhD CALGB Statistical Office at Duke University Medical Center
Alliance for Clinical Trials in Oncology
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP