PanCystPro test to guide management of pancreatic cysts
Official title: Clinical Utility Study to Determine Impact of PanCystPro Assay on Physician Decision-making in the Management of Pancreatic Cystic Lesions
Run by Amplified Sciences Inc · NCT06894329 · Data updated 2026-11-12
This test tries to see if the PanCystPro cyst-fluid assay can help doctors decide treatment and monitoring for adults with pancreatic cysts undergoing endoscopic ultrasound needle biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Amplified Sciences Inc Industry-sponsored |
| Locations | 3 sites (Indianapolis, Indiana and 2 other locations) |
| Status | Recruiting |
| Started | February 17, 2026 |
| Main results expected | November 30, 2026 |
| Study ends | July 31, 2027 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT06894329 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a pancreatic cyst at least 12 mm on imaging who are scheduled for EUS with anticipated FNA and can provide informed consent are ideal candidates.
✕Probably not a fit
Patients with known pancreatic cancer, those not undergoing cyst fluid sampling, pregnant or lactating individuals, or patients with contraindications to sedation or FNA are unlikely to benefit from this test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study in which a sample of pancreatic cyst fluid obtained during standard-of-care EUS-FNA is sent to the Amplified lab for PanCystPro testing. The assay measures glucose, carcinoembryonic antigen (CEA), and gastricsin and classifies cyst fluid as "Non-mucinous" or "Mucinous." After the PanCystPro result is returned, clinicians record their intended clinical management, and the actual management received by the patient is documented one year after enrollment. The study enrolls adults with radiographically confirmed pancreatic cysts planned for EUS-FNA at participating U.S. centers.
Why it matters
Potential benefit: If successful, PanCystPro could help doctors better distinguish higher-risk mucinous cysts from low-risk non-mucinous cysts, potentially reducing unnecessary surgery and focusing follow-up on patients who need it most.
How similar studies have gone: Previous studies have shown cyst fluid markers like CEA and glucose can help distinguish mucinous from non-mucinous cysts, but combining those markers with gastricsin in the PanCystPro panel is relatively new and still being tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Indiana University
Indianapolis, Indiana, United States Recruiting -
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
Rutgers Health
New Brunswick, New Jersey, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.