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RecruitingNCT06894329PanAMPUpdated Mar 16, 2026

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

An observational study in Pancreatic Cystic Lesions, sponsored by Amplified Sciences Inc. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Amplified Sciences Inc · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2026; still recruiting 7 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreatic Cystic Lesions
03

In context

Lead sponsor

This is the only study on the registry with Amplified Sciences Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with radiographically confirmed pancreatic cysts planned for EUS-FNA.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 1 month.

07

Study locations

3 of 3 sites recruiting
  • Indiana University
    Indianapolis, Indiana 46202, United States
    Recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
    Recruiting
  • Rutgers Health
    New Brunswick, New Jersey 08901, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06894329
Lead sponsor
Amplified Sciences Inc
Responsible party
Sponsor
First posted
Mar 25, 2025
Start date
Feb 17, 2026
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Mar 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

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