RNA Sequencing of Solid and Cystic Lesions of the Pancreas

January 7, 2020 updated by: Oregon Health and Science University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97229
        • Providence St Vincent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult, nonpregnant patients referred for endoscopic ultrasound to evaluate solid or cystic lesion of the pancreas.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pancreas cysts and solid masses
patents referred for solid and cystic lesions of the pancreas who will have a biopsy for usual medical care.
Procedure: pancreas biopsy
patients who are already having a pancreas biopsy will be invited to enroll. After obtaining enough tissue for usual medical care, we will divert some tissue for the study.
Other Names:
  • RNA sequencing of pancreas tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gene classifier that will classify lesions as benign or malignant with 95% certainty
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Providence Health & Services

Investigators

  • Principal Investigator: Sarah Rodriguez, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB8317

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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