Studying Biomarkers in Patients With Pancreatic Cancer
This study is currently recruiting participants.
Verified March 2013 by Vanderbilt-Ingram Cancer Center
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00900003
First received: May 9, 2009
Last updated: March 2, 2013
Last verified: March 2013
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Purpose
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 | Intervention |
|---|---|
|
Pancreatic Cancer |
Genetic: protein analysis Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Developing Biomarkers in Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Examine the location of BRCA1 in the cells and determine if this location predicts patient response to the chemotherapy drugs given
Secondary Outcome Measures:
- Correlation of pre-treatment markers with survival and recurrence [ Time Frame: at expiration date of final patient enrolled ] [ Designated as safety issue: No ]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
- 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 ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900003
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Bapsi Chak 615-322-2555 | |
| Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Bapsi Chak 615-322-2555 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Study Chair: | A. Bapsi Chakravarthy, MD | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | A Bapsi Chakravarthy, MD, Associate Professor; Radiation Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00900003 History of Changes |
| Other Study ID Numbers: | VICC GI 0717, P30CA068485, VU-VICC-GI-0717, VU-VICC-070366 |
| Study First Received: | May 9, 2009 |
| Last Updated: | March 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013