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CompletedNCT00900016Updated Sep 11, 2017

Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

An observational study in Pancreatic Cancer, sponsored by Fox Chase Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-09-11.

Sponsored by Fox Chase Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
37
Sex
All
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 37 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Surgury patients scheduled to undergo a resection or exploration of their pancreatic tumor

Eligibility 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Geneticprotein expression analysis
  • Geneticwestern blotting
  • Otherimmunohistochemistry staining method
  • Otherimmunologic technique
  • Otherlaboratory biomarker analysis
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What researchers measure

Primary outcomes

  1. Independence of tumor fibroblast activation protein (FAP) activity and Met-α2-antiplasmin expression

    Time frame: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence

Secondary outcomes

  1. Feasibility of exploiting the circulatory compartment to identify surrogates of tumor FAP

    Time frame: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence

  2. Potential plasma surrogates of plasma dipeptidyl peptidase activity and plasma antiplasmin converting enzyme

    Time frame: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence

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Study locations

1 site
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania 19111-2497, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00900016
Lead sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Aug 2007
Primary completion
Dec 2013
Completion
Jun 23, 2017
Last update
Sep 11, 2017

Study contacts

Steven Cohen, MD
principal investigator · Fox Chase Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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