RecruitingNCT06894329

A Study for the PanCystPro Assay in the Management of Pancreatic Cystic Lesions

Clinical Utility Study to Determine Impact of PanCystPro Assay on Physician Decision-making in the Management of Pancreatic Cystic Lesions

Sponsor

Amplified Sciences Inc

Enrollment

50 participants

Start Date

Feb 17, 2026

Study Type

OBSERVATIONAL

Conditions

Pancreatic Cystic Lesions

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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.

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