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

Completed

• Conditions: Pancreatic Cancer
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT00897832
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-02
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pancreatic cancer	laboratory biomarker analysis	Patients with pancreatic cancer

Primary Outcome Measures

Name	Time	Method
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	1 year following final patient data

Trial Locations

Locations (3)

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, United States