NCT06894329

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Amplified Sciences Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective observational study to assess the impact of PanCystPro in patients with radiographically confirmed pancreatic cysts planned for Endoscopic Ultra Sound (EUS) Fine Needle Aspirate (FNA). Eligible subjects will be enrolled after signing the ICF. One pancreatic cyst sample will be sent to the Amplified lab for PanCystPro testing. The impact of PanCystPro on clinical management intention will be assessed after the PanCystPro result has been received by the physician. One year after enrollment the actual clinical management the patient received will be assessed.

Conditions

• Pancreatic Cystic Lesions

Timeline

• Start date: 2026-02-17
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2025-03-25
• Last updated: 2026-03-16

Locations

3 sites across 1 country: United States