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Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00897832
First Posted: May 12, 2009
Last Update Posted: March 5, 2013
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
  Purpose

RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers in predicting response to treatment in patients who have undergone surgery for pancreatic cancer.


Condition Intervention
Pancreatic Cancer Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Developing Predictive Markers of Therapeutic Response in Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Determination if a method of extracting and identifying biomarkers from tissues of the quantity obtained from typical biopsy can be applied in the setting of pancreatic cancer [ Time Frame: 1 year following final patient data ]

Estimated Enrollment: 50
Study Start Date: January 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pancreatic cancer
Patients with pancreatic cancer
Other: laboratory biomarker analysis
Using material that is already being acquired as a component of clinical care (only that which is excess after routine clinical care), it will be determined 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.

Detailed Description:

OBJECTIVES:

  • To determine if a method of extracting and identifying biomarkers (i.e., secreted cytokines and growth factors) from tissues of the quantity obtained from typical biopsy can now be applied in the setting of pancreatic cancer
  • To correlate pre-treatment biomarkers with recurrence, overall survival, and tumor response to radiotherapy and chemotherapy in patients with pancreatic cancer.

OUTLINE: Tumor tissue specimens are obtained from the Vanderbilt Ingram Cancer Center Human Tissue Acquisition Core and analyzed for biomarkers (e.g., integrity of DNA repair pathways as analyzed by Rad51 and phosphorylated DNA-PK foci formation). The biomarkers are correlated with clinical outcomes (recurrence, overall survival, and tumor response to treatment).

Patients are followed for recurrence, relapse, and death from disease.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pancreatic cancer
Criteria

Inclusion criteria

  • Diagnosis of pancreatic cancer
  • Excess tissue collected at the time of routine surgery for pancreatic cancer must be available for analysis

Exclusion criteria

  • None known
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897832


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: A Bapsi Chakravarthy, MD, Associate Professor; Radiation Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00897832     History of Changes
Other Study ID Numbers: VICC GI 0666
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-GI-0666
VU-VICC-061225
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center:
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