DNA Microarray Study of Pancreas Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by Oregon Health and Science University. Recruitment status was Not yet recruiting

First Received on May 16, 2008. No Changes Posted

Sponsor:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00680420

Purpose

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.

Condition	Intervention
Pancreas Cancer	Procedure: fine needle aspiration biopsy

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	DNA Microarray Analysis of Endoscopic Ultrasound-Guided Fine Needle Aspiration Biopsies to Discriminate Benign From Malignant Pancreatic Lesions

Resource links provided by NLM:

MedlinePlus related topics: Cancer Endoscopy Pancreatic Cancer Ultrasound

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Gene expression profile is 95% accurate in diagnosis of malignancy [ Time Frame: after enrollment of 50 patients ] [ Designated as safety issue: No ]

Estimated Enrollment:	99
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

One extra biopsy will be taken from the pancreas only in patients who are already undergoing biopsy of a mass or cyst.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680420

Contacts

Contact: Sarah A Rodriguez, MD	(503)494-8311	rodrigue@ohsu.edu
Contact: Douglas O Faigel, MD	(503)494-8311	faigeld@ohsu.edu

Locations

United States, Oregon
Oregon Health and Science University	Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Sarah Rodriguez, MD 503-494-8311 rodrigue@ohsu.edu
Principal Investigator: Sarah A Rodriguez, MD
Sub-Investigator: Douglas O Faigel, MD
Sub-Investigator: Terry Morgan, MD
Sub-Investigator: Brett Sheppard, MD

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:

Sarah Rodriguez, MD

Oregon Health and Science University

More Information

No publications provided

Responsible Party:	Sarah Rodriguez, M.D., Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00680420 History of Changes
Other Study ID Numbers:	IRB4191
Study First Received:	May 16, 2008
Last Updated:	May 16, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

pancreas cancer
pancreas cyst
DNA microarray

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases

Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012