DNA Microarray Study of Pancreas Cancer

Pancreas Cancer Clinical Trial

Official title:

DNA Microarray Analysis of Endoscopic Ultrasound-Guided Fine Needle Aspiration Biopsies to Discriminate Benign From Malignant Pancreatic Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680420
• Other study ID #: IRB4191
• Status: Completed
• Phase: N/A
• First received: May 16, 2008
• Last updated: March 6, 2013
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2013
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression profile is 95% accurate in diagnosis of malignancy		after enrollment of 50 patients	No