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2007-05
2013-03
2013-03
53
NCT00900003
Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
OBSERVATIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2009-05-09 | N/A | 2013-12-10 |
2009-05-09 | N/A | 2013-12-12 |
2009-05-12 | N/A | 2013-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : pancreatic cancer patients pancreatic cancer patients with excess tissue collected at the time of standard of care surgery | GENETIC: protein analysis
OTHER: laboratory biomarker analysis
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
