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.
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
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Contacts