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Developing Biomarkers in Pancreatic Cancer


N/A
N/A
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Developing Biomarkers in Pancreatic Cancer


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.

Inclusion Criteria


Inclusion criteria

- Any subject with excess tissue collected at time of routine surgery for pancreatic
cancer is eligible.

- All subjects participating in this protocol will be followed for recurrence, relapse
and death from disease

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

Examine the location of BRCA1 in the cells and determine if this location predicts patient response to the chemotherapy drugs given

Outcome Time Frame:

following collection of all pancreatic tissue specimens and patient outcome data

Safety Issue:

No

Principal Investigator

A. Bapsi Chakravarthy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

VICC GI 0717

NCT ID:

NCT00900003

Start Date:

May 2007

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064