Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900016
• Other study ID #: CDR0000579635
• Secondary ID: 07-011
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: September 8, 2017
• Start date: August 2007
• Est. completion date: June 23, 2017

Study information

• Verified date: September 2017
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 23, 2017
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Genetic:
• protein expression analysis

• western blotting

Other:
• immunohistochemistry staining method

• immunologic technique

• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Independence of tumor fibroblast activation protein (FAP) activity and Met-a2-antiplasmin expression		Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
Secondary	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
Secondary	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