Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening

Recruiting N/A Interventional Study
Pancreas Cancer Pancreatic Ductal Adenocarcinoma Hereditary Diseases Pancreatitis, Chronic
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Screening
Participants needed
419 (estimated)
Sponsor
Lipidica, a.s. · Industry
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About This Trial
Software "Lipidica" is intended to be used for processing data generated by the in-house in vitro diagnostic medical device for lipidomic testing for the purpose of screening Pancreatic cancer (PaC) in the population at high risk of this cancer due to familial risk, selected gene mutations or hereditary pancreatic diseases. The primary objective is to verify that the investigational IVDSW can dis…
Trial Locations
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Eligibility Criteria
Inclusion Criteria Arm1: * Age ≥ 18 years * Signed informed consent * Histologically confirmed diagnosis of resectable PaC Exclusion Criteria Arm 1: * History of any other cancer disease * Present incurable malignancy * Unfit for radical curative resection of the tumor * Vegan or vegetarian diet …
Contacts

Karolina Kasparova

+420723 242 544

karolina.kasparova@lipidica.cz

CONTACT