Studying Biomarkers in Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Developing Biomarkers in Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Genetic: protein analysis
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pancreatic cancer patients<br>pancreatic cancer patients with excess tissue collected at the time of standard of care surgery | Genetic: protein analysis<br>* Using material that is already being acquired as a component of clinical care (only that which is excess after routine clinical care), we will determine if pre-treatment markers can be used to correlate with clinical outcomes of survival and recurrence. Examples of such markers include studying if the integrity of DNA repair pathway in pancreatic cancers, analyzed by Rad51 and phosphorylated DNA-PK foci formation, correlates with tumor response to radiotherapy, chemotherapy, and overall survival. The markers targeted are proteins secreted by cancer cells and/or cancer associated cells.<br>Other: laboratory biomarker analysis<br>* A method of extracting and identifying secreted cytokines and growth factors from tissues of the quantity of typical biopsy tissues has been developed.The purpose of this study is to determine if this method of biomarker discovery can now be applied to pancreatic cancer population.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of pre-treatment markers with survival and recurrence | 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 | 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 | 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 | upon collection of pancreatic tissue for each patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer