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Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00900016
First received: May 9, 2009
Last updated: June 9, 2009
Last verified: June 2009
History of Changes

May 9, 2009
June 9, 2009
August 2007
August 2009   (final data collection date for primary outcome measure)
Independence of tumor fibroblast activation protein (FAP) activity and Met-α2-antiplasmin expression [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00900016 on ClinicalTrials.gov Archive Site
  • Feasibility of exploiting the circulatory compartment to identify surrogates of tumor FAP [ Designated as safety issue: No ]
  • Potential plasma surrogates of plasma dipeptidyl peptidase activity and plasma antiplasmin converting enzyme [ Designated as safety issue: No ]
Same as current
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Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery
Pharmacodynamic Study of Fibroblast Activity Protein in Patients With Localized Pancreas Cancer Undergoing Surgical Resection

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.
Observational
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Pancreatic Cancer
  • Genetic: protein expression analysis
  • Genetic: western blotting
  • Other: immunohistochemistry staining method
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
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August 2009   (final data collection date for primary outcome measure)

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
Both
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No
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United States
 
NCT00900016
CDR0000579635, FCCC-07011
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Fox Chase Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Jonathan Cheng, MD Fox Chase Cancer Center
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP