DNA Microarray Study of Pancreas Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarah Rodriguez, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00680420
First received: May 16, 2008
Last updated: March 6, 2013
Last verified: March 2013
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:


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 ]

Enrollment: 27
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with suspected pancreas mass

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
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, Physician, 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: March 6, 2013
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 Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014