Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery

NCT00900016 | Completed

• 2 other identifiers: CDR000057963507-011
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage I pancreatic cancer; stage II pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

protein expression analysis GENETIC

western blotting GENETIC

immunohistochemistry staining method OTHER

immunologic technique OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgury patients scheduled to undergo a resection or exploration of their pancreatic tumor

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood sample

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blotting, Western; Immunohistochemistry; Immunologic Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrophoresis; Chemistry Techniques, Analytical; Investigative Techniques; Electrochemical Techniques; Immunoblotting; Immunoassay; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques

Study Officials

• Steven Cohen, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: August 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: June 23, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

US (1)