RNA Sequencing of Solid and Cystic Lesions of the Pancreas

Completed

• Conditions: Pancreas Cyst; Pancreas Mass
• Interventions: Procedure: pancreas biopsy

• Registration Number: NCT01807325
• Lead Sponsor: Oregon Health and Science University

Brief Summary

The nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may be benign, precancerous, or cancer. Current tests such as cytology (looking under a microscope) and tumor markers do not always give us the answer. The investigators are looking for genetic markers on biopsy specimens from the pancreas that will give us a better test for diagnosis. This study is only for diagnosing these lesions. The investigators are not treating any patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-08
• Primary Completion: 2017-12
• Study Completion: 2019-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• greater than 18 years old,
• not pregnant,
• referred for endoscopic ultrasound,
• have a cyst or mass of the pancreas needing diagnosis.

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Exclusion Criteria

• pregnant,
• less than age 18,
• no mass or cyst found.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pancreas cysts and solid masses	pancreas biopsy	patents referred for solid and cystic lesions of the pancreas who will have a biopsy for usual medical care.

Primary Outcome Measures

Name	Time	Method
Gene classifier that will classify lesions as benign or malignant with 95% certainty	2 years

Trial Locations

Locations (2)

Providence St Vincent Hospital; 🇺🇸 Portland, Oregon, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States