NCT02110498

Brief Summary

This research is being done to learn more about pancreatic cysts. The tests that are currently available are imperfect at determining exactly what type of pancreatic cyst a person has, which cysts contain cancer, or what the risk is of developing cancer in the future. The aim of this study is to use a combination of clinical, imaging, cyst fluid analysis, and molecular markers to try to help develop better tools to answer these questions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

11 years

First QC Date

March 30, 2014

Last Update Submit

February 26, 2026

Conditions

Pancreatic CystsIntraductal Papillary Mucinous NeoplasmPancreatic Mucinous-Cystic NeoplasmCystic, Mucinous and/or Serous NeoplasmSolid Pseudopapillary Tumour of the Pancreas

Keywords

Pancreatic cystIPMNSCASPNMCNpancreatic cystic neoplasm

Outcome Measures

Primary Outcomes (1)

  • To develop and prospectively validate a panel of molecular markers to differentiate benign pancreatic cysts from those with malignant potential using surgical pathology as the gold standard

    3 years

Secondary Outcomes (1)

  • To determine the sensitivity, specificity, and overall accuracy of imaging (CT, MRI and EUS) in patients with pancreatic cysts

    3 years

Other Outcomes (1)

  • To determine the proportion of patients with malignancy in operable pancreatic cysts

    3 years

Eligibility Criteria

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

Any individual with a pancreatic cyst seen at the Johns Hopkins Hospital or other participating Institutions.

You may qualify if:

  • Adult patients age 18 years and older with pancreatic cyst.

You may not qualify if:

  • Individuals with ASA class 4 or greater.
  • Inability to provide informed consent.
  • Pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pancreatic cyst fluid, blood

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Officials

  • Anne Marie O'Broin-Lennon, MD, PhD

    Johns Hopkins 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 30, 2014

First Posted

April 10, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

US(1)