Official Title: “DNA Microarray Analysis of Endoscopic Ultrasound-Guided Fine Needle Aspiration Biopsies to Discriminate Benign From Malignant Pancreatic Lesions”

Pancreas cancer and precancerous cysts can be difficult to diagnose. Sometimes biopsies do not show cancer when cancer is actually present. We hypothesize that genetic differences exist in tissue that is malignant compared to nonmalignant. When patients present with a pancreas mass or cyst, we biopsy it by fine-needle aspiration during upper endoscopy with ultrasound guidance. We would like to use tissue obtained via endoscopic ultrasound guided fine needle aspiration to perform DNA microarray analysis, and compare the differences in gene expression level in the benign tissue compared to cancerous tissue in order to improve our diagnostic capabilities. DNA microarray measures gene expression level rather than germline mutations. The true diagnosis will be based on cytology, surgical pathology, or clinical followup. The performance of the microarray test as a diagnostic test will be compared to the performance of cytology.

Study Type: Interventional

Study Design: Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

• Procedure: fine needle aspiration biopsy
  • One extra biopsy will be taken from the pancreas only in patients who are already undergoing biopsy of a mass or cyst.

Primary Measures

• Gene expression profile is 95% accurate in diagnosis of malignancy
  • Time Frame: after enrollment of 50 patients
    Safety Issue?: No

Inclusion Criteria:

• Adults aged 18 or older who are able to give informed consent who present for an endoscopic ultrasound to evaluate a pancreas mass or cyst or for suspicion of cancer.

Exclusion Criteria:

• Unable to give informed consent, pregnant or nursing, contraindication to endoscopic ultrasound, no mass or cyst found on ultrasound

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Oregon Health and Science University

Overall Clinical Trial Officials and Contacts

Sarah Rodriguez, MD Principal Investigator Oregon Health and Science University  

Overall Contact: Sarah A Rodriguez, MD (503)494-8311 rodrigue@ohsu.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00680420

Study ID Number: IRB4191

ClinicalTrials.gov Identifier: NCT00680420

Health Authority: United States: Institutional Review Board