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NCT Number: NCT00900003

Studying Biomarkers in Patients With Pancreatic Cancer

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

protein analysis

Genetic

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.

laboratory biomarker analysis

Other

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.

Primary outcomes

  1. 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

  1. Correlation of pre-treatment markers with survival and recurrence

    Time frame: 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

  2. Application of a method of extracting and identifying secreted cytokines and growth factors from biopsy tissue to the pancreatic cancer population

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Developing Biomarkers in Pancreatic Cancer

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
May 12, 2009
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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