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Studying Biomarkers in Patients With Pancreatic Cancer

This study has been completed.
Sponsor:
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: December 10, 2013
Last verified: December 2013
  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


Enrollment: 53
Study Start Date: May 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900003

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
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: December 10, 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 Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014