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Completed

NCT Number: NCT00900016

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

protein expression analysis

Genetic

western blotting

Genetic

immunohistochemistry staining method

Other

immunologic technique

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pharmacodynamic Study of Fibroblast Activity Protein in Patients With Localized Pancreas Cancer Undergoing Surgical Resection

Important dates

Study start
2007
Primary completion
2013
Study completion
2017
First posted
May 12, 2009
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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