DNA Microarray Study of Pancreas Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680420
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : March 7, 2013
Information provided by (Responsible Party):
Sarah Rodriguez, Oregon Health and Science University

Brief 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.

Condition or disease Intervention/treatment
Pancreas Cancer Procedure: fine needle aspiration biopsy

Study Type : Observational
Actual Enrollment : 27 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Gene expression profile is 95% accurate in diagnosis of malignancy [ Time Frame: after enrollment of 50 patients ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with suspected pancreas mass

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680420

United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: Sarah Rodriguez, MD Oregon Health and Science University

Responsible Party: Sarah Rodriguez, Physician, Oregon Health and Science University Identifier: NCT00680420     History of Changes
Other Study ID Numbers: IRB4191
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Sarah Rodriguez, Oregon Health and Science University:
pancreas cancer
pancreas cyst
DNA microarray

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Agents