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DNA Microarray Study of Pancreas Cancer

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreas Cancer

Intervention: fine needle aspiration biopsy (Procedure)

Phase: N/A

Status: Completed

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

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: Observational Model: Cohort, Time Perspective: Prospective

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

Oregon Health and Science University, Portland, Oregon 97239, United States
Additional Information

Starting date: June 2008
Last updated: March 6, 2013

Page last updated: August 23, 2015

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