Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

NCT ID: NCT00900016

Last Updated: 2017-09-11

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

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2017-06-23

Brief Summary

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RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is assessing fibroblast activity in patients with localized pancreatic cancer undergoing surgery.

Detailed Description

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OBJECTIVES:

Primary

* To assess the degree of fibroblast activation protein (FAP) enzymatic activity at the tumor site in patients with localized pancreatic cancer.

Secondary

* To explore correlations between tumor stromal FAP enzymatic activity and stromal α\_2-antiplasmin levels.
* To explore correlations between tumor FAP enzymatic activity and plasma dipeptidyl peptidase and plasma α\_2-antiplasmin converting enzyme activity as potential surrogates.

OUTLINE: Patients undergo fine-needle aspiration of tumor or suspected mass at baseline. Tumor samples are analyzed by IHC for fibroblast activation protein (FAP) expression, immunocapture assay for ex vivo FAP enzymatic activity, and western analysis for FAP concentrations. Blood samples are collected weekly and analyzed for dipeptidyl peptidase activity by ELISA and α\_2-antiplasmin converting enzyme.

Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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protein expression analysis

Intervention Type GENETIC

western blotting

Intervention Type GENETIC

immunohistochemistry staining method

Intervention Type OTHER

immunologic technique

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Biopsy-proven adenocarcinoma of the pancreas or pancreatic mass suspicious for pancreatic cancer
* Localized disease
* Scheduled to undergo a resection or exploration of their pancreatic tumor

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

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Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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07-011

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000579635

Identifier Type: -

Identifier Source: org_study_id

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