A Study for the PanCystPro Assay in the Management of Pancreatic Cystic Lesions
ConditionPancreatic Cystic Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAmplified Sciences Inc
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with radiographically confirmed pancreatic cysts planned for EUS-FNA.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov