Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Fox Chase Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00900016
First received: May 9, 2009
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Pancreatic Cancer
Genetic: protein expression analysis
Genetic: western blotting
Other: immunohistochemistry staining method
Other: immunologic technique
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacodynamic Study of Fibroblast Activity Protein in Patients With Localized Pancreas Cancer Undergoing Surgical Resection

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

peripheral blood sample


Estimated Enrollment: 40
Study Start Date: August 2007
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900016

Locations
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi    215-728-4790      
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Steven Cohen, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00900016     History of Changes
Other Study ID Numbers: CDR0000579635, 07-011
Study First Received: May 9, 2009
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fox Chase Cancer Center:
adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage I pancreatic cancer
stage II pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014