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Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery


2007-08


2013-12


2017-06-23


37

Study Overview

Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

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.

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.

  • Pancreatic Cancer
  • GENETIC: protein expression analysis
  • GENETIC: western blotting
  • OTHER: immunohistochemistry staining method
  • OTHER: immunologic technique
  • OTHER: laboratory biomarker analysis
  • CDR0000579635
  • 07-011 (OTHER Identifier) (OTHER: Fox Chase Cancer Center)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2009-05-09  

N/A  

2017-09-08  

2009-05-09  

N/A  

2017-09-11  

2009-05-12  

N/A  

2017-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
Independence of tumor fibroblast activation protein (FAP) activity and Met-α2-antiplasmin expressionWithin 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Feasibility of exploiting the circulatory compartment to identify surrogates of tumor FAPWithin 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
Potential plasma surrogates of plasma dipeptidyl peptidase activity and plasma antiplasmin converting enzymeWithin 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • National Cancer Institute (NCI)

  • PRINCIPAL_INVESTIGATOR: Steven Cohen, MD, Fox Chase Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available