Studying Biomarkers in Patients With Pancreatic Cancer
Developing Biomarkers in Pancreatic Cancer
4 other identifiers
observational
53
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2007
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedDecember 12, 2013
December 1, 2013
5.8 years
May 9, 2009
December 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Correlation of pre-treatment markers with survival and recurrence
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
upon collection of pancreatic tissue for each patient
Study Arms (1)
pancreatic cancer patients
pancreatic cancer patients with excess tissue collected at the time of standard of care surgery
Interventions
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.
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
patients with cancer of the pancreas
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
A. Bapsi Chakravarthy, MD
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor; Radiation Oncologist
Study Record Dates
First Submitted
May 9, 2009
First Posted
May 12, 2009
Study Start
May 1, 2007
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
December 12, 2013
Record last verified: 2013-12