Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery
|ClinicalTrials.gov Identifier: NCT00900016|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : September 11, 2017
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 or disease||Intervention/treatment|
|Pancreatic Cancer||Genetic: protein expression analysis Genetic: western blotting Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Pharmacodynamic Study of Fibroblast Activity Protein in Patients With Localized Pancreas Cancer Undergoing Surgical Resection|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||June 23, 2017|
- 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 ]
- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900016
|United States, Pennsylvania|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||Steven Cohen, MD||Fox Chase Cancer Center|