NCT01807325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

5 years

First QC Date

March 6, 2013

Last Update Submit

January 7, 2020

Conditions

Pancreas CystPancreas Mass

Outcome Measures

Primary Outcomes (1)

  • Gene classifier that will classify lesions as benign or malignant with 95% certainty

    2 years

Study Arms (1)

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

pancreas biopsyPROCEDURE

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.

Also known as: RNA sequencing of pancreas tissue
pancreas cysts and solid masses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Providence St Vincent Hospital

Portland, Oregon, 97229, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

pancreas biopsies

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Officials

  • Sarah Rodriguez, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 8, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

US(2)