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

NCT ID: NCT01664169

Last Updated: 2019-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

307 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

laboratory biomarker analysis

Intervention Type OTHER

Interventions

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laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients must have been registered to CALGB-80303

* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced or metastatic disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herbert Pang, PhD

Role: PRINCIPAL_INVESTIGATOR

CALGB Statistical Office at Duke University Medical Center

Other Identifiers

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CDR0000738204

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-01994

Identifier Type: REGISTRY

Identifier Source: secondary_id

A151201

Identifier Type: -

Identifier Source: org_study_id

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