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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLipidica, a.s.

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 discriminate between results of patients with Pancreatic cancer and persons without Pancreatic cancer but at higher risk of this cancer disease due to their predispositions.

Participants will:

* come to baseline and end of study visit for blood sampling and medical imaging * some participant will undertake one more visit depending on their results on baseline

Eligibility criteria

Qualifiers

Age ≥ 18 years

Signed informed consent

Histologically confirmed diagnosis of resectable PaC

Disqualifiers

History of any other cancer disease

Present incurable malignancy

Unfit for radical curative resection of the tumor

Vegan or vegetarian diet

Trial design

Treatments tested in this trial

  • software Lipidica
  • endoscopic ultrasonography
  • magnetic resonance
  • laboratory examination
  • computed tomography

Treatment groups

419 Participants
are divided into 2 treatment groups

Sponsors and collaborators