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Studying Biomarkers in Patients With Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00900003
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : December 12, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment
Pancreatic Cancer Genetic: protein analysis Other: laboratory biomarker analysis

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 Design
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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Developing Biomarkers in Pancreatic Cancer
Study Start Date : May 2007
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
pancreatic cancer patients
pancreatic cancer patients with excess tissue collected at the time of standard of care surgery
 Genetic: protein analysis
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.

Other: laboratory biomarker analysis
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with cancer of the pancreas
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900003


Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
More Information
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Additional Information:

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Responsible Party: A Bapsi Chakravarthy, MD, Associate Professor; Radiation Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00900003    
Other Study ID Numbers: VICC GI 0717
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-GI-0717
VU-VICC-070366
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013
Keywords provided by A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center:
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases