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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The percentage of subjects for which the providers indicated positive impact of the PanCystPro assay. — 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.
Trial sites (3)
Facility
City
Region
Status
Indiana University
Indianapolis
Indiana
Recruiting
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Recruiting
Rutgers Health
New Brunswick
New Jersey
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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