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

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.

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Key information

Conditions

Pancreatic Cystic Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University, Indianapolis, Indiana, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: 1 month.

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.

Sponsors and collaborators

Lead sponsor

Amplified Sciences Inc

Industry

Registry information

Official study title

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

Acronym: PanAMP

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Mar 25, 2025
Registry last updated: Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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