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NCT00900003 Clinical Trial

Studying Biomarkers in Patients With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
Developing Biomarkers in Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00900003
Other study ID # VICC GI 0717
Secondary ID P30CA068485VU-VI
Status Completed
Phase N/A
First received May 9, 2009
Last updated December 10, 2013
Start date May 2007
Est. completion date March 2013

Study information
Verified date December 2013
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center - Cool Springs Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center at Franklin Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
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