RNA Sequencing of Solid and Cystic Lesions of the Pancreas

Pancreas Cyst Clinical Trial

Official title:

RNA Sequencing of Solid and Cystic Lesions of the Pancreas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807325
• Other study ID #: IRB8317
• Status: Completed
• Start date: December 2012
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Cyst
• Pancreas Mass
• Pancreatic Cyst

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon
United States	Providence St Vincent Hospital	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene classifier that will classify lesions as benign or malignant with 95% certainty		2 years