Studying Biomarkers in Patients With Pancreatic Cancer

Completed

• Conditions: Pancreatic Cancer
• Interventions: Genetic: protein analysis; Other: laboratory biomarker analysis

• Registration Number: NCT00900003
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with pancreatic cancer.

Detailed Description

OBJECTIVES:

* To determine whether the cellular localization of BRCA1 can predict how patients with pancreatic cancer will respond to cytotoxic agents (e.g., fluorouracil or gemcitabine hydrochloride) or radiotherapy.

* To identify pre-treatment markers that can be used to correlate with clinical outcomes of survival and recurrence.

* To determine if a method of extracting and identifying secreted cytokines and growth factors from biopsy tissue can now be applied to the pancreatic cancer population.

OUTLINE: Tissue samples from biopsies performed during pancreatectomy are collected from the Vanderbilt Ingram Cancer Center Human Tissue Acquisition Core for laboratory biomarker studies. Proteins secreted by cancer cells and/or cancer-associated cells are studied by extracting and identifying secreted cytokines and growth factors from biopsy tissue. The integrity of the DNA repair pathway in pancreatic cancer is analyzed by Rad51 and phosphorylated DNA-PK foci formation. Markers are correlated with clinical outcome.

Patients are followed for recurrence, relapse, and death from disease.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pancreatic cancer patients	protein analysis	pancreatic cancer patients with excess tissue collected at the time of standard of care surgery
pancreatic cancer patients	laboratory biomarker analysis	pancreatic cancer patients with excess tissue collected at the time of standard of care surgery

Primary Outcome Measures

Name	Time	Method
Cellular localization of BRCA1 as a predictor of response to cytotoxic agents or radiotherapy	following collection of all pancreatic tissue specimens and patient outcome data	Examine the location of BRCA1 in the cells and determine if this location predicts patient response to the chemotherapy drugs given

Secondary Outcome Measures

Name	Time	Method
Correlation of pre-treatment markers with survival and recurrence	at expiration date of final patient enrolled	Compare and contract of biomarkers in patient's tissue that are detected before treatment has a relationship to their survival and recurrence of their cancer
Application of a method of extracting and identifying secreted cytokines and growth factors from biopsy tissue to the pancreatic cancer population	upon collection of pancreatic tissue for each patient	Researchers will determine if the methods they have developed for extracting and identifying cytokines in biopsy tissue can be applied to the pancreatic cancer tissue

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States