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

Study on Pancreatic Cyst Management Using Investigational Assay

M
Mohammad Al-Haddad, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
10 participants needed
2 Locations

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY -   Patients with radiographically confirmed pancreatic cysts planned for EUS-FNA will be identified and contacted about study participation.

Detailed description of 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatic Cystic Lesions
  • Age: 18 years - 100 years
  • Gender: All

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.

This study investigates the use of an investigational assay called PanCystPro to help doctors make decisions about treating pancreatic cysts. Pancreatic cysts are fluid-filled sacs on the pancreas, and some can lead to cancer. The PanCystPro test measures certain substances in the cyst fluid to determine if the cyst is more likely to become cancerous.

Participants will undergo a procedure called Endoscopic Ultrasound with Fine Needle Aspirate (EUS-FNA) to collect a fluid sample from the pancreatic cyst. This sample will be tested with PanCystPro. The study will observe how this test affects the doctors' treatment plans and check the actual treatment given one year later.

  • Who can participate: Adults aged 18 and older with a pancreatic cyst at least 12 mm in size, who are scheduled for EUS-FNA, can participate. Participants must give written consent and not have pancreatic cancer, be pregnant, or have certain medical conditions that prevent safe participation.
  • Study details: Participants will have a pancreatic cyst fluid sample taken during a standard care procedure. This sample is tested with the investigational assay to help doctors decide on management plans.
Updated on 02 Dec 2025. Study ID: GI-AMPLIFIED-PANAMP, 26825
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only