Pancreas CancerNCT06549725
Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
A study testing software Lipidica, endoscopic ultrasonography and magnetic resonance in people with Pancreas Cancer and Pancreatic Ductal Adenocarcinoma, run by Lipidica, a.s. at 16 sites in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreas Cancer, Pancreatic Ductal Adenocarcinoma, Hereditary Diseases
- What is being tested?
- software Lipidica, endoscopic ultrasonography and magnetic resonance
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 16 sitesCzechia
- Study dates
- 10 Sep 2024to 26 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Signed informed consent
- Histologically confirmed diagnosis of resectable PaC
- Age ≥ 18 years
- Signed informed consent
- High risk of PaC due to the presence of one of the following risk factors:
Show all 17Show fewer
- 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)
- Person with CDKN2A mutation: > 40 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
- Person with APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 mutation: > 45 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
- Person with hereditary pancreatitis: > 40 years or 20 years after the 1st attack (whichever comes first)
Who cannot join
- History of any other cancer disease
- Present incurable malignancy
- Unfit for radical curative resection of the tumor
- Vegan or vegetarian diet
- Pregnancy of planning to conceive in the next 12 months
- History of any cancer disease
Show all 9Show fewer
- Present incurable malignancy
- Inability to undergo planned medical imaging or blood sampling
- Vegan or vegetarian diet
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Czechia16 sites, 16 recruiting
- Recruiting
Fakultni nemocnice Brno
Brno
Jan Hlavsa, Hlavsa.Jan@fnbrno.cz
Jan Hlavsa
- Recruiting
Fakultni nemocnice u sv. Anny
Brno
Katarina Glombova, katarina.glombova@fnusa.cz
Katarina Glombova
- Recruiting
Masarykuv onkologicky ustav
Brno
Martina Lojova, martina.lojova@mou.cz
Jan Trna
- Recruiting
Nemocnice Ceske Budejovice
České Budějovice
Barbora Varejkova, varejkova.barbora@nemcb.cz
Filip Shon
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové
Veronika Knoblochova, veronika.knoblochva@fnhk.cz
Tomas Douda
- Not yet recruiting
Nemocnice Jablonec nad Nisou
Jablonec nad Nisou
Robert Prochazka, +420721122793, prochazka@nemjbc.cz
Robert Prochazka
- Recruiting
Fakultni nemocnice Olomouc
Olomouc
Ondrej Urban, Ondrej.urban@fnol.cz
Ondrej Urban
- Recruiting
Nemocnice Pardubickeho kraje
Pardubice
Jiri Drahos, jan.drahos@nempk.cz
Petr Vyhnalek
- Recruiting
Fakultni nemocnice Plzen
Pilsen
Vaclav Hejda, HEJDAV@fnplzen.cz
Vaclav Hejda
- Recruiting
Ustredni vojenska nemocnice
Prague, Czechia
Jan Csomor, +420973203028, Jan.Csomor@uvn.cz
Jan Csomor
- Recruiting
Fakultni nemocnice Bulovka
Prague
Robert Grulich, robert.grulich@bulovka.cz
Robert Grulich
- Recruiting
Fakultni nemocnice Kralovske Vinohrady
Prague
Marketa Hlatka, marketa.hlatka@fnkv.cz
Martin Oliverius
- Recruiting
Fakultni Thomayerova nemocnice
Prague
Jiri Skopek, jiri.skopek1@ftn.cz
Pavel Kohout
- Recruiting
Institut klinicke a experimentalni mediciny
Prague
Tomas Hucl, tomas.hucl@ikem.cz
Tomas Hucl
- Recruiting
Vseobecna fakultni nemocnice
Prague
Zuzana Namestkova, Zuzana.Namestkova@vfn.cz
Michal Vocka
- Recruiting
Masarykova nemocnice v Usti nad Labem
Ústí nad Labem
Jakub Stehlik, Jakub.stehlik@kzcr.eu
Jiri Stehlik
About this study
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.
Read more
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
Read the detailed description
Pancreatic cancer (PaC) is one of the cancer diseases with the worst prognosis, as mortality almost equals the incidence. In the Czech Republic, the incidence of pancreatic ductal adenocarcinoma (PDAC) has had a clear upward trend since the late 1970s, and in 2018, 21.9 new cases per 100,000 persons were reported.
PDAC is associated with a poor prognosis for several reasons. Due to the usual asymptomatic course or occurrence of only non-specific symptoms, it is usually detected in an advanced stage. Moreover, the diagnosis by standard methods can be difficult in the early stages, and investigators lack sensitive and specific tumor markers. The disease forms distant metastases rapidly, which creates a very short time interval for effective curative interventions. So far, PaC screening possibilities in the Czech Republic are limited to several academic research screening cohorts.
Five-year survival, regardless of clinical stage, is 7-9%. The resectable disease is detected in 10% of patients with a 5-year survival of 42%. Locally advanced unresectable disease is found in about 30% of patients with a 5-year survival of 12%, and metastatic disease is diagnosed in about 60% of patients with a 5-year survival of only approx. 3%.
PaC screening is not suitable for an unselected population. By contrast, it is vital for individuals with a high risk of developing this disease due to family history and/or genetic predispositions. Early diagnosis resulted in more curative resections and longer survival in this population thanks to the screening programs. First economic evaluations described the possible cost-effectiveness of screening high-risk individuals.
Changes in plasma lipid concentrations were reported in various cancer types (bladder, breast, colorectal, gastric, liver, kidney, lung, oesophageal, ovarian, prostate, thyroid, and pancreas). The altered plasma lipid profile may originate not only from tumor cells, tumor stroma, and apoptotic cells but also from an immune response.
Previous study robustly proved a specific lipidomic phenotype in patients with PDAC across stages, age, treatments, or the presence of diabetes. Multiple lipid species were significantly downregulated in the plasma of PDAC patients, such as very long-chain monounsaturated sphingomyelins, ceramides and (lyso)phosphatidylcholines. The study showed that lipid profiling can discriminate between patients with PDAC and healthy controls or patients with pancreatitis. This clinical performance study (CPS) follows on from the previous study by Wolrab et al.
- Conditions
- Pancreas Cancer, Pancreatic Ductal Adenocarcinoma, Hereditary Diseases, Pancreatitis, Chronic
- Being tested
- software Lipidica, endoscopic ultrasonography, magnetic resonance, laboratory examination, computed tomography
- Medical subject headings
- Pancreatic Neoplasms, Genetic Diseases, Inborn, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
software LipidicaDevice
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.
endoscopic ultrasonographyProcedure or surgery
Also called EUS
Endoscopic ultrasonography - maximum frequency: 3 times during the participation
magnetic resonanceProcedure or surgery
Also called MR
Magnetic resonance - maximum frequency: 3 times during the participation
laboratory examinationDiagnostic test
Lipidomic analysis, CA 19-9, CEA, HbA1c and hCG levels assessment (hCG only in women of childbearing potential in Arm 2)
computed tomographyProcedure or surgery
Also called CT
computed tomography - maximum frequency: 3 times during the participation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: software Lipidica; Procedure: endoscopic ultrasonography; Procedure: magnetic resonance; Diagnostic Test: laboratory examination; Procedure: computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Interim analysis 1 year from first subject enrolled and through study completion (an average of 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start10 Sep 2024
- Primary completion26 Sep 2027 (estimated)
- Study completion26 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 419 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lipidica, a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karolina Kasparova, Study director, Lipidica, a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549725
- Sponsor's protocol ID
- Lipidica_01-2024
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
- ClinicalTrials.gov ID
- NCT06549725
- Acronym / sponsor ID
- Lipidica_01-2024
- Conditions
- Pancreas Cancer, Pancreatic Ductal Adenocarcinoma, Hereditary Diseases, Pancreatitis, Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 419 participants (estimated)
- Lead sponsor
- Lipidica, a.s.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 26 Sep 2027 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Pancreatic cancer (PaC) is one of the cancer diseases with the worst prognosis, as mortality almost equals the incidence. In the Czech Republic, the incidence of pancreatic ductal adenocarcinoma (PDAC) has had a clear upward trend since the late 1970s, and in 2018, 21.9 new cases per 100,000 persons were reported.
PDAC is associated with a poor prognosis for several reasons. Due to the usual asymptomatic course or occurrence of only non-specific symptoms, it is usually detected in an advanced stage. Moreover, the diagnosis by standard methods can be difficult in the early stages, and investigators lack sensitive and specific tumor markers. The disease forms distant metastases rapidly, which creates a very short time interval for effective curative interventions. So far, PaC screening possibilities in the Czech Republic are limited to several academic research screening cohorts.
Five-year survival, regardless of clinical stage, is 7-9%. The resectable disease is detected in 10% of patients with a 5-year survival of 42%. Locally advanced unresectable disease is found in about 30% of patients with a 5-year survival of 12%, and metastatic disease is diagnosed in about 60% of patients with a 5-year survival of only approx. 3%.
PaC screening is not suitable for an unselected population. By contrast, it is vital for individuals with a high risk of developing this disease due to family history and/or genetic predispositions. Early diagnosis resulted in more curative resections and longer survival in this population thanks to the screening programs. First economic evaluations described the possible cost-effectiveness of screening high-risk individuals.
Changes in plasma lipid concentrations were reported in various cancer types (bladder, breast, colorectal, gastric, liver, kidney, lung, oesophageal, ovarian, prostate, thyroid, and pancreas). The altered plasma lipid profile may originate not only from tumor cells, tumor stroma, and apoptotic cells but also from an immune response.
Previous study robustly proved a specific lipidomic phenotype in patients with PDAC across stages, age, treatments, or the presence of diabetes. Multiple lipid species were significantly downregulated in the plasma of PDAC patients, such as very long-chain monounsaturated sphingomyelins, ceramides and (lyso)phosphatidylcholines. The study showed that lipid profiling can discriminate between patients with PDAC and healthy controls or patients with pancreatitis. This clinical performance study (CPS) follows on from the previous study by Wolrab et al.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients with Pancreatic cancer | Active comparator | Device: software Lipidica, Diagnostic Test: laboratory examinationParticipants 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. |
| Patient at risk of Pancreatic cancer | Experimental | Device: software Lipidica, Procedure: endoscopic ultrasonography, Procedure: magnetic resonance, Diagnostic Test: laboratory examination, Procedure: computed tomographyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years
- Signed informed consent
- Histologically confirmed diagnosis of resectable PaC
- Age ≥ 18 years
- Signed informed consent
Key exclusion criteria (9 listed)
- History of any other cancer disease
- Present incurable malignancy
- Unfit for radical curative resection of the tumor
- Vegan or vegetarian diet
- Pregnancy of planning to conceive in the next 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| software LipidicaThe 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. | Device | Patient at risk of Pancreatic cancer, Patients with Pancreatic cancer |
| endoscopic ultrasonographyAlso: EUSEndoscopic ultrasonography - maximum frequency: 3 times during the participation | Procedure or surgery | Patient at risk of Pancreatic cancer |
| magnetic resonanceAlso: MRMagnetic resonance - maximum frequency: 3 times during the participation | Procedure or surgery | Patient at risk of Pancreatic cancer |
| laboratory examinationLipidomic analysis, CA 19-9, CEA, HbA1c and hCG levels assessment (hCG only in women of childbearing potential in Arm 2) | Diagnostic test | Patient at risk of Pancreatic cancer, Patients with Pancreatic cancer |
| computed tomographyAlso: CTcomputed tomography - maximum frequency: 3 times during the participation | Procedure or surgery | Patient at risk of Pancreatic cancer |
Primary outcome
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.
Time frame: Interim analysis 1 year from first subject enrolled and through study completion (an average of 3 years)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karolina Kasparova study director
Lipidica, a.s.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing software Lipidica, endoscopic ultrasonography and magnetic resonance in people with Pancreas Cancer and Pancreatic Ductal Adenocarcinoma, run by Lipidica, a.s. at 16 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karolina Kasparova (+420723 242 544, karolina.kasparova@lipidica.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Interim analysis 1 year from first subject enrolled and through study completion (an average of 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.