Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery
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.
Genetic: protein expression analysis
Genetic: western blotting
Other: immunohistochemistry staining method
Other: immunologic technique
Other: laboratory biomarker analysis
|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|
- 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 ]
- 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
|Study Start Date:||August 2007|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
- To assess the degree of fibroblast activation protein (FAP) enzymatic activity at the tumor site in patients with localized pancreatic cancer.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900016
|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|
|Principal Investigator:||Steven Cohen, MD||Fox Chase Cancer Center|