DNA Microarray Study of Pancreas Cancer
Information source: Oregon Health and Science University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreas Cancer
Intervention: fine needle aspiration biopsy (Procedure)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s):
Sarah Rodriguez, MD, Principal Investigator, Affiliation: Oregon Health and Science University
Overall contact:
Sarah A Rodriguez, MD, Phone: (503)494-8311, Email: rodrigue@ohsu.edu
Summary
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.
Clinical Details
Official title: DNA Microarray Analysis of Endoscopic Ultrasound-Guided Fine Needle Aspiration Biopsies to Discriminate Benign From Malignant Pancreatic Lesions
Study design: Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Gene expression profile is 95% accurate in diagnosis of malignancy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Sarah A Rodriguez, MD, Phone: (503)494-8311, Email: rodrigue@ohsu.edu
Oregon Health and Science University, Portland, Oregon 97239, United States
Additional Information
Starting date: June 2008
Ending date: June 2011
Last updated: May 16, 2008
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