RNA Sequencing of Solid and Cystic Lesions of the Pancreas | NCT01807325

Studies
RNA Sequencing of Solid and Cystic Lesions of the Pancreas

NCT01807325

Sponsor

Oregon Health and Science University

Status

Completed

Last Update Posted

Jan 10, 2020Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Pancreas Cyst
Pancreas Mass

Interventions

pancreas biopsy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2019Actual

First Submitted Date

Mar 6, 2013

First Submission Date that Met QC Criteria

Mar 7, 2013

First Posted Date

Mar 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2020

Last Update Posted Date

Jan 10, 2020Actual

Name	Class
Providence Health & Services	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pancreas biopsy	Procedure	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Rodriguez, MD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Providence St Vincent Hospital		Portland	Oregon	97229	United States
Oregon Health and Science University

Condition Browse Module

MeSH Terms

ID	Term
D010181	Pancreatic Cyst

Ancestor Terms

ID	Term
D003560	Cysts
D009369	Neoplasms
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided