NCT06894329

Brief Summary

The purpose of this research is to learn if the PanCystPro assay can help doctors in making decisions about treatment and monitoring of pancreatic cysts. The PanCystPro test measures glucose, carcinoembryonic antigen (CEA), and gastricsin biomarkers on fluid obtained from a pancreatic cyst. The test reports if the cyst fluid should be considered "Non-mucinous" or "Mucinous". Mucinous pancreatic cysts are more likely to progress to cancer while non-mucinous cysts seldom progress to cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Feb 2026

Geographic Reach
1 country

3 active sites

Status
recruiting

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 Progress16%
Feb 2026Jun 2027

First Submitted

Initial submission to the registry

March 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

February 17, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 19, 2025

Last Update Submit

March 12, 2026

Conditions

Pancreatic Cystic Lesions

Outcome Measures

Primary Outcomes (1)

  • The percentage of subjects for which the providers indicated positive impact of the PanCystPro assay.

    The percentage of subjects for which the providers indicated positive impact on patient management decisions of the PanCystPro assay results in patients with radiographically confirmed pancreatic cysts.

    1 month.

Eligibility Criteria

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

Patients with radiographically confirmed pancreatic cysts planned for EUS-FNA.

You may qualify if:

  • Patients 18 years of age or older
  • Cross sectional imaging studies demonstrating a pancreatic cyst at least 12 mm in size where fluid sampling can aid in patient's management
  • Written informed consent.
  • The patient will be undergoing EUS with anticipated FNA extraction as part of standard patient care.

You may not qualify if:

  • Patients diagnosed with pancreatic cancer.
  • Pregnant or lactating females.
  • Patients with contraindications to moderate or deep procedural sedation (necessary for the conduct of the endoscopic ultrasound) like major cardiorespiratory illness.
  • Patients with contraindications to FNA of a pancreatic cyst like being on blood thinners.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Rutgers Health

New Brunswick, New Jersey, 08901, United States

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 25, 2025

Study Start

February 17, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

US(3)