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Clinical Trials/NCT00900003
NCT00900003
Completed
Not Applicable

Developing Biomarkers in Pancreatic Cancer

Vanderbilt-Ingram Cancer Center3 sites in 1 country53 target enrollmentMay 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Vanderbilt-Ingram Cancer Center
Enrollment
53
Locations
3
Primary Endpoint
Cellular localization of BRCA1 as a predictor of response to cytotoxic agents or radiotherapy
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
March 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

A Bapsi Chakravarthy, MD

Associate Professor; Radiation Oncologist

Vanderbilt-Ingram Cancer Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cellular localization of BRCA1 as a predictor of response to cytotoxic agents or radiotherapy

Time Frame: 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 Outcomes

  • Correlation of pre-treatment markers with survival and recurrence(at expiration date of final patient enrolled)
  • 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)

Study Sites (3)

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