Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT00900016
• Lead Sponsor: Fox Chase Cancer Center

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2013-12
• Study Completion: 2017-06-23
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Fox Chase Cancer Center - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States