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Sponsored by: |
Oregon Health and Science University |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00680420 |
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 |
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Pancreas Cancer |
Procedure: fine needle aspiration biopsy |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | DNA Microarray Analysis of Endoscopic Ultrasound-Guided Fine Needle Aspiration Biopsies to Discriminate Benign From Malignant Pancreatic Lesions |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sarah A Rodriguez, MD | (503)494-8311 | rodrigue@ohsu.edu |
Contact: Douglas O Faigel, MD | (503)494-8311 | faigeld@ohsu.edu |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Sarah Rodriguez, MD | Oregon Health and Science University |
Responsible Party: | Oregon Health and Science University ( Sarah Rodriguez, M.D. ) |
Study ID Numbers: | IRB4191 |
Study First Received: | May 16, 2008 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00680420 |
Health Authority: | United States: Institutional Review Board |
pancreas cancer pancreas cyst DNA microarray |
Digestive System Diseases Digestive System Neoplasms Pancreatic Cyst Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Cysts Pancrelipase Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |