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Blood test software could spot pancreatic cancer early in High-Risk groups

NCT ID NCT06549725

Diagnosis Sponsor: Lipidica, a.s. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a software called Lipidica that analyzes fats in the blood to help screen for pancreatic cancer. Researchers will compare results from people with pancreatic cancer to those at high risk (due to family history or genetic factors) to see if the software can tell them apart. About 419 participants will provide blood samples and undergo imaging tests like endoscopic ultrasound or MRI. The goal is to see if this non-invasive approach can improve early detection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lipidica 1.0 software (medical device software for analyzing lipidomic data)
What this could lead to
If successful, this could provide a simple blood test to screen for pancreatic cancer in people at high risk, potentially catching the disease earlier.
What could go wrong
This is an early-stage study focused on accuracy, not treatment. The software may not be sensitive or specific enough to reliably detect cancer, and results may not apply to the general population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 419 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Inclusion Criteria Arm2: * Age ≥ 18 years * Signed informed consent * High risk of PaC due to the presence of one of the following risk factors: 1. Family history of PaC (≥ 2 first-degree or second-degree relatives with PaC in the same family line) 2. Confirmed germline mutation of STK11 (LKB1) regardless of family history 3. Confirmed germline mutation of CDKN2A leading to the alteration of p16 regardless of family history 4. 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 5. Present hereditary pancreatitis (recurrent acute pancreatitis or chronic pancreatitis and confirmed germline mutation of PRSS1) * Age: 1. 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) 2. Person with STK11 mutation: \> 35 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first) 3. Person with CDKN2A mutation: \> 40 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first) 4. 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) 5. Person with hereditary pancreatitis: \> 40 years or 20 years after the 1st attack (whichever comes first) Exclusion Criteria Arm 2: * Pregnancy of planning to conceive in the next 12 months * History of any cancer disease * Present incurable malignancy * Inability to undergo planned medical imaging or blood sampling * Vegan or vegetarian diet

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Conditions

The condition(s) this trial relates to.

chronic pancreatitis hereditary disease malignant pancreatic neoplasm pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary diseases Pancreas cancer Pancreatic ductal adenocarcinoma Pancreatitis, chronic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fakultni Thomayerova nemocnice

    RECRUITING

    Prague, Czechia

  • Fakultni nemocnice Brno

    RECRUITING

    Brno, Czechia

  • Fakultni nemocnice Bulovka

    RECRUITING

    Prague, Czechia

  • Fakultni nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    RECRUITING

    Prague, Czechia

  • Fakultni nemocnice Olomouc

    RECRUITING

    Olomouc, Czechia

  • Fakultni nemocnice Plzen

    RECRUITING

    Pilsen, Czechia

  • Fakultni nemocnice u sv. Anny

    RECRUITING

    Brno, Czechia

  • Institut klinicke a experimentalni mediciny

    RECRUITING

    Prague, Czechia

  • Masarykova nemocnice v Usti nad Labem

    RECRUITING

    Ústí nad Labem, Czechia

  • Masarykuv onkologicky ustav

    RECRUITING

    Brno, Czechia

  • Nemocnice Ceske Budejovice

    RECRUITING

    České Budějovice, Czechia

  • Nemocnice Jablonec nad Nisou

    NOT_YET_RECRUITING

    Jablonec nad Nisou, Czechia

  • Nemocnice Pardubickeho kraje

    RECRUITING

    Pardubice, Czechia

  • Ustredni vojenska nemocnice

    RECRUITING

    Prague, Czechia, Czechia

  • Vseobecna fakultni nemocnice

    RECRUITING

    Prague, Czechia

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