2007-08
2013-12
2017-06-23
37
NCT00900016
Fox Chase Cancer Center
Fox Chase Cancer Center
OBSERVATIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2009-05-09 | N/A | 2017-09-08 |
2009-05-09 | N/A | 2017-09-11 |
2009-05-12 | N/A | 2017-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
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Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Independence of tumor fibroblast activation protein (FAP) activity and Met-α2-antiplasmin expression | Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
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 | |
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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available