Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

Pharmacodynamic Study of Fibroblast Activity Protein in Patients With Localized Pancreas Cancer Undergoing Surgical Resection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00900016

Enrollment

Registered

2009-05-12

Start date

2007-08-31

Completion date

2017-06-23

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer

Brief 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.

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.

Interventions

GENETICprotein expression analysis

GENETICwestern blotting

OTHERimmunohistochemistry staining method

OTHERimmunologic technique

OTHERlaboratory biomarker analysis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Independence of tumor fibroblast activation protein (FAP) activity and Met-α2-antiplasmin expression	Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence

Secondary

Measure	Time frame
Feasibility of exploiting the circulatory compartment to identify surrogates of tumor FAP	Within 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 enzyme	Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026