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

NCT06549725 | Recruiting

• 1 other identifier: Lipidica_01-2024
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 16

Brief 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

Pancreas Cancer; Hereditary Diseases; Pancreatic Ductal Adenocarcinoma; Pancreatitis, Chronic

Outcome Measures

Primary Outcomes (1)

• The primary objective is to verify that the investigational IVDSW can discriminate between results of patients with PaC and persons without PaC but at higher risk of this cancer disease due to their predispositions.

  The primary objective will be assessed using the following parameters: Diagnostic sensitivity The sensitivity is defined as the capacity to correctly detect confirmed positive samples of plasma from patient with PaC diagnosed with standard diagnostic methods. Diagnostic specificity The specificity is the ability to correctly classify samples of plasma from patient without PaC but at higher risk of the disease. The diagnosis of PaC will be excluded using standard diagnostic methods. Positive predictive value It is the ratio of patients with PaC truly diagnosed as positive to all those who had positive results (including healthy subjects who were incorrectly diagnosed as patients with PaC). Negative predictive value It is the ratio of subjects truly diagnosed as negative to all those who had negative results (including patients with PaC who were incorrectly diagnosed as healthy). Likelihood ratio and Expected values in normal and affected populations

  Interim analysis 1 year from first subject enrolled and through study completion (an average of 3 years)

Other Outcomes (5)

• Glycosylated haemoglobin (HbA1c) levels with PaC diagnosis status

  Through study completion (an average of 3 years)

• Effect of CA 19-9 and CEA tumor markers on sensitivity and specificity

  Through study completion (an average of 3 years)

• Several predefined cut-off values

  Through study completion (an average of 3 years)

Study Arms (2)

Patients with Pancreatic cancer

ACTIVE COMPARATOR

Participants with histologically confirmed diagnosis of resectable Pancreatic cancer. Arm 1 will undertake one visit (baseline) for blood sampling - lipidomics, CA 19-9 and CEA, HbA1c. At baseline their participation ends.

Device: software Lipidica; Diagnostic Test: laboratory examination

Patient at risk of Pancreatic cancer

EXPERIMENTAL

Participants without Pancreatic cancer but at higher risk of this cancer disease due to their predispositions. Arm 2 will come for two or three visits depending on results at baseline. On each visit blood sampling (lipidomics, CA 19-9 and CEA, HbA1c, hCG) and medical imaging by EUS, MR or CT will be performed. Their participation ends with the diagnosis of Pancreatic cancer or after 12 months of follow-up.

Device: software Lipidica; Procedure: endoscopic ultrasonography; Procedure: magnetic resonance; Diagnostic Test: laboratory examination; Procedure: computed tomography

Interventions

software Lipidica DEVICE

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.

Patient at risk of Pancreatic cancer; Patients with Pancreatic cancer

endoscopic ultrasonography PROCEDURE

Endoscopic ultrasonography - maximum frequency: 3 times during the participation

Also known as: EUS

Patient at risk of Pancreatic cancer

magnetic resonance PROCEDURE

Magnetic resonance - maximum frequency: 3 times during the participation

Also known as: MR

Patient at risk of Pancreatic cancer

laboratory examination DIAGNOSTIC_TEST

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

Patient at risk of Pancreatic cancer; Patients with Pancreatic cancer

computed tomography PROCEDURE

computed tomography - maximum frequency: 3 times during the participation

Also known as: CT

Patient at risk of Pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Signed informed consent
• Histologically confirmed diagnosis of resectable PaC

You may not qualify if:

• History of any other cancer disease
• Present incurable malignancy
• Unfit for radical curative resection of the tumor
• Vegan or vegetarian diet
• Age ≥ 18 years
• Signed informed consent
• High risk of PaC due to the presence of one of the following risk factors:
• Family history of PaC (≥ 2 first-degree or second-degree relatives with PaC in the same family line)
• Confirmed germline mutation of STK11 (LKB1) regardless of family history
• Confirmed germline mutation of CDKN2A leading to the alteration of p16 regardless of family history
• Confirmed germline mutation of APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 AND ≥ 1 first-degree or second-degree relative with PaC
• Present hereditary pancreatitis (recurrent acute pancreatitis or chronic pancreatitis and confirmed germline mutation of PRSS1)
• Age:
• Person with a family history of PaC: \> 50 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
• Person with STK11 mutation: \> 35 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)

Sponsors & Collaborators

• Lipidica, a.s.: lead

Study Sites (16)

Ustredni vojenska nemocnice

Prague, Czechia, Czechia

RECRUITING

Fakultni nemocnice Brno

Brno, Czechia

RECRUITING

Fakultni nemocnice u sv. Anny

Brno, Czechia

RECRUITING

Masarykuv onkologicky ustav

Brno, Czechia

RECRUITING

Nemocnice Ceske Budejovice

České Budějovice, Czechia

RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

RECRUITING

Nemocnice Jablonec nad Nisou

Jablonec nad Nisou, Czechia

NOT YET RECRUITING

Fakultni nemocnice Olomouc

Olomouc, Czechia

RECRUITING

Nemocnice Pardubickeho kraje

Pardubice, Czechia

RECRUITING

Fakultni nemocnice Plzen

Pilsen, Czechia

RECRUITING

Fakultni nemocnice Bulovka

Prague, Czechia

RECRUITING

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

RECRUITING

Fakultni Thomayerova nemocnice

Prague, Czechia

RECRUITING

Institut klinicke a experimentalni mediciny

Prague, Czechia

RECRUITING

Vseobecna fakultni nemocnice

Prague, Czechia

RECRUITING

Masarykova nemocnice v Usti nad Labem

Ústí nad Labem, Czechia

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Genetic Diseases, Inborn; Pancreatitis, Chronic

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Karolina Kasparova

  Lipidica, a.s.

  STUDY DIRECTOR

Central Study Contacts

Karolina Kasparova

CONTACT

+420723 242 544; karolina.kasparova@lipidica.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The laboratory personnel performing the lipidomic testing and using the investigated medical device software will be blinded to the allocation of the participants/ samples.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm 1: Histologically confirmed diagnosis of resectable Pancreatic cancer Arm 2: Participants without PaC but at higher risk of Pancreatic cancer disease due to their predispositions

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 12, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): September 26, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CZ (16)