Recruiting

PanCystPro

Sponsor:

Amplified Sciences Inc

Code:

NCT06894329

Conditions

Pancreatic Cystic Lesions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Pancreatic Cystic Lesions

Study ID

NCT06894329

Start date

Feb 17, 2026

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • The percentage of subjects for which the providers indicated positive impact of the PanCystPro assay. [ Time Frame: 1 month. ]

Central Contacts and Locations

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Mohammad Al-Haddad, MD

317-278-9242petermaj@iu.edu

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Mandeep Sawhney, MD

617-667-4046rdastjer@bidmc.harvard.edu

Rutgers Health

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Arvind Trindade, MD

732-235-7784molly.stewart1@rutgers.edu

More Information

Sponsor

Amplified Sciences Inc

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Amplified Sciences Inc on 2026-03-16.