RNA Sequencing of Solid and Cystic Lesions of the Pancreas

Sponsor

Oregon Health and Science University (Other)

Overall Status

Completed

CT.gov ID

NCT01807325

Collaborator

Providence Health & Services (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cyst Pancreas Mass	Procedure: pancreas biopsy

Study Design

Study Type:

Observational

Actual Enrollment :

72 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

RNA Sequencing of Solid and Cystic Lesions of the Pancreas

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Gene classifier that will classify lesions as benign or malignant with 95% certainty [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence St Vincent Hospital	Portland	Oregon	United States	97229
2	Oregon Health and Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

Oregon Health and Science University
Providence Health & Services

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT01807325

Other Study ID Numbers:

IRB8317

First Posted:

Mar 8, 2013

Last Update Posted:

Jan 10, 2020

Last Verified:

Jan 1, 2020

Additional relevant MeSH terms:

Pancreatic Cyst

Pancrelipase

Pancreatin

Study Results

No Results Posted as of Jan 10, 2020