Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
53 participants
OBSERVATIONAL
2007-05-31
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This research study is studying biomarkers in patients with pancreatic cancer.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
pancreatic cancer patients
pancreatic cancer patients with excess tissue collected at the time of standard of care surgery
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All subjects participating in this protocol will be followed for recurrence, relapse and death from disease
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
A Bapsi Chakravarthy, MD
Associate Professor; Radiation Oncologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
A. Bapsi Chakravarthy, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VU-VICC-GI-0717
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-070366
Identifier Type: -
Identifier Source: secondary_id
VICC GI 0717
Identifier Type: -
Identifier Source: org_study_id