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Trial record 12 of 2867 for:    Pancreatic Cancer

Studying Biomarkers in Patients With Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00900003
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : December 12, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date December 12, 2013
Study Start Date May 2007
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2013)
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 ]
Examine the location of BRCA1 in the cells and determine if this location predicts patient response to the chemotherapy drugs given
Original Primary Outcome Measures
 (submitted: May 9, 2009)
  • Cellular localization of BRCA1 in predicting how patients with pancreatic cancer will respond to cytotoxic agents or radiotherapy
  • Correlation of pre-treatment markers with survival and recurrence
  • Application of a method of extracting and identifying secreted cytokines and growth factors from biopsy tissue to the pancreatic cancer population
Change History Complete list of historical versions of study NCT00900003 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 2, 2013)
  • Correlation of pre-treatment markers with survival and recurrence [ Time Frame: at expiration date of final patient enrolled ]
    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 ]
    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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Studying Biomarkers in Patients With Pancreatic Cancer
Official Title Developing Biomarkers in Pancreatic Cancer
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.

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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with cancer of the pancreas
Condition Pancreatic Cancer
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.
Study Groups/Cohorts pancreatic cancer patients
pancreatic cancer patients with excess tissue collected at the time of standard of care surgery
Interventions:
  • Genetic: protein analysis
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 10, 2013)
53
Original Enrollment Not Provided
Actual Study Completion Date March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00900003
Other Study ID Numbers VICC GI 0717
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-GI-0717
VU-VICC-070366
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
Study Sponsor Vanderbilt-Ingram Cancer Center
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date December 2013