Clinical trial NCT00900016: Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery
Official title: Pharmacodynamic Study of Fibroblast Activity Protein in Patients With Localized Pancreas Cancer Undergoing Surgical Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage I pancreatic cancer
stage II pancreatic cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgury patients scheduled to undergo a resection or exploration of their pancreatic tumor

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.

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

Primary outcomes:
measure: Independence of tumor fibroblast activation protein (FAP) activity and Met-α2-antiplasmin expression
timeFrame: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
Secondary outcomes:
measure: Feasibility of exploiting the circulatory compartment to identify surrogates of tumor FAP
timeFrame: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
measure: Potential plasma surrogates of plasma dipeptidyl peptidase activity and plasma antiplasmin converting enzyme
timeFrame: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Steven Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: