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

NCT06549725 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2026-04-27

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

software Lipidica

The investigational in vitro diagnostic medical device-software (IVDSW) "Lipidica" processes and analyses data inputs from the analysis of lipid profile in human plasma using an in-house in vitro diagnostic medical device.

PROCEDURE

endoscopic ultrasonography

Endoscopic ultrasonography - maximum frequency: 3 times during the participation

PROCEDURE

magnetic resonance

Magnetic resonance - maximum frequency: 3 times during the participation

DIAGNOSTIC_TEST

laboratory examination

Lipidomic analysis, CA 19-9, CEA, HbA1c and hCG levels assessment (hCG only in women of childbearing potential in Arm 2)

PROCEDURE

computed tomography

computed tomography - maximum frequency: 3 times during the participation

Sponsors & Collaborators

  • Lipidica, a.s.

    lead INDUSTRY

Principal Investigators

  • Karolina Kasparova · Lipidica, a.s.

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2027-09-26
Completion
2027-09-26

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549725 on ClinicalTrials.gov