Liver DiseasesLIVER-TRACKNCT07185360
Liver Diseases: Extracellular Vesicles as Biomarkers
A study testing blood sampling for volunteers, blood sampling for diabetics patients with F3/F4 fibrosis and blood sampling for patients with liver disease in people with Liver Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Worldwide, cirrhosis is responsible for 2 million deaths per year. Hepatocellular carcinoma (HCC) accounts for 800,000 of these deaths and is the 3rd leading cause of cancer related death. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- blood sampling for volunteers, blood sampling for diabetics patients with F3/F4 fibrosis and blood sampling for patients with liver disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 845 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2025to 31 Mar 2028
- 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
- Patient aged 18 or over
- Type 2 diabetic (ADA/WHO criteria recalled in section 20.5)
- Hepatic fibrosis stage F3/F4 on liver biopsy or hepatic elasticity > 10 kPa
- Major
- Child-Pugh A, B or C cirrhosis, diagnosed on the basis of histological evidence or liver elasticity > 15 kPa or a combination of biological and radiological signs.
Who cannot join
- Known liver disease
- Active cancer
- Viral or bacterial infection within 2 weeks of inclusion (respiratory, dermatological, urinary, digestive, etc.)
- Transfusion in the month preceding inclusion
- Current participation or less than 3 months' participation in a therapeutic interventional trial
- Absence of signed informed consent
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- Not affiliated to a social security scheme
- Pregnant women
- Person under guardianship or trusteeship
- Diabetic patients with F3/F4 fibrosis recruited and followed prospectively
- Vulnerable person: a person deprived of liberty by a judicial or administrative decision, or under psychiatric care, and a person admitted to a health or social institution for purposes other than research.
- Protected adult
- Not affiliated to or not benefiting from a social security scheme
- Pregnant or breast-feeding women
- Absence of signed informed consent
- Illness linked to other etiologies:
- Alcoholic liver disease
- Current hepatitis B virus infection
- Current hepatitis C virus infection
- Autoimmune hepatitis according to according to AASLD and EASL recommended criteria
- Transferrin saturation >50%
- Alpha antitrypsin ZZ or SZ type deficiency
- Wilson's disease
- Liver transplant patients
- Ultrasound obstruction of blood vessels or bile ducts (on routine ultrasound). If nothing is mentioned on the report, it is considered that there is no obstruction of the blood vessels or bile ducts).
- Current participation or less than 3 months' participation in a therapeutic interventional trial
- Patients with liver disease :
- Presence of one of the following diseases in the 15 days prior to inclusion: acute renal failure, bacterial infection (proven or suspected on clinico-biological criteria), digestive bleeding,
- alcoholic hepatitis in the month prior to inclusion
- Previous porto-systemic shunt, liver transplantation, primary sclerosing cholangitis, primary biliary cholangitis, Budd-Chiari syndrome
- Active or past hepatocellular carcinoma
- Active extrahepatic neoplasia,
- Current participation or less than 3 months' participation in a therapeutic interventional trial
- Absence of signed informed consent
- Non affiliation to a social security scheme
- Pregnant or breast-feeding
- Person under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Bichat Hospital, Beaujon Hospital, Cochin Hospital and Lariboisière Hospital
Paris, France
Pierre Emmanuel RAUTOU, +33 1 40 87 52 83, pierre-emmanuel.rautou@aphp.fr
About this study
Worldwide, cirrhosis is responsible for 2 million deaths per year. Hepatocellular carcinoma (HCC) accounts for 800,000 of these deaths and is the 3rd leading cause of cancer related death. Cirrhosis affects mainly a working age population, hence its heavy economic burden.While patients with compensated cirrhosis do not have symptoms and have a 10-year life expectancy, decompensation of cirrhosis heralds a dramatic decrease in life expectancy to 2 years. Biomarkers allowing reliable estimation of the risk for decompensation of cirrhosis would allow community-based care, possibly by nurse practitioners, of patients at low risk, while patients had high risk could be managed in secondary and tertiary care centers and included in clinical trials. Because HCC is usually asymptomatic at early stages, when it is still curable, it can easily be missed. Biomarkers allowing stratification of the risk of HCC would allow reinforced surveillance (using magnetic resonance imaging) of high-risk patients, and their inclusion in chemoprevention clinical trials.
LIVER-TRACK aims at reliably predicting the outcome of patients with compensated cirrhosis through the development of a Tests for Decompensation and a Test for HCC. This will be achieved through leveraging circulating extracellular vesicles (EVs), an untapped source of biomarkers in liver diseases, as prognostic indicators, and combining them with existing blood biomarkers and single-nucleotide polymorphisms (SNPs). LIVER-TRACK also aims at delivering technologies for EV measurement that are useable in medical practice.
Read the detailed description
Worldwide, cirrhosis is responsible for 2 million deaths per year. Hepatocellular carcinoma (HCC) accounts for 800,000 of these deaths and is the 3rd leading cause of cancer related death. Cirrhosis affects mainly a working age population, hence its heavy economic burden. While patients with compensated cirrhosis do not have symptoms and have a 10-year life expectancy, decompensation of cirrhosis heralds a dramatic decrease in life expectancy to 2 years. Biomarkers allowing reliable estimation of the risk for decompensation of cirrhosis would allow community-based care, possibly by nurse practitioners, of patients at low risk, while patients had high risk could be managed in secondary and tertiary care centers and included in clinical trials. Because HCC is usually asymptomatic at early stages, when it is still curable, it can easily be missed. Biomarkers allowing stratification of the risk of HCC would allow reinforced surveillance (using magnetic resonance imaging) of high-risk patients, and their inclusion in chemoprevention clinical trials.
LIVER-TRACK aims at reliably predicting the outcome of patients with compensated cirrhosis through the development of a Tests for Decompensation and a Test for HCC. This will be achieved through leveraging circulating extracellular vesicles (EVs), an untapped source of biomarkers in liver diseases, as prognostic indicators, and combining them with existing blood biomarkers and single-nucleotide polymorphisms (SNPs). LIVER-TRACK also aims at delivering technologies for EV measurement that are useable in medical practice.
LIVER-TRACK outputs are expected to: i) improve care for individual patients at highest medical need, i.e., patients with cirrhosis with high risk of decompensation or HCC; ii) decrease cirrhosis burden for public health, iii) facilitate drug development; and iv) technically allow exploitation of EVs as biomarkers in clinical practice, an obligatory step permitting expansion to other fields such as cancer and cardiovascular diseases.
- Conditions
- Liver Diseases
- Being tested
- blood sampling for volunteers, blood sampling for diabetics patients with F3/F4 fibrosis, blood sampling for patients with liver disease
- Keywords
- liver decompensation, extracellular vesicles, hepatocellular carcinoma, cirrhosis
- Medical subject headings
- Liver Diseases, Hepatic Insufficiency, Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling for volunteersOther
A 38.5 ml blood sample will be taken to test for research taken to test for research
blood sampling for diabetics patients with F3/F4 fibrosisOther
32.5 ml will be sampled at inclusion, at one year visit and two year visit
blood sampling for patients with liver diseaseOther
A blood sample of 35.5 mL maximum will be taken for research purposes at the inclusion visit, M1 visit and M3 visit.
| Study group | Role | What they receive |
|---|---|---|
| Volunteers without liver disease | Other | Volunteers without liver disease Receives: Other: blood sampling for volunteers |
| Diabetic patients with F3/F4 fibrosis recruited and followed prospectively | Other | Diabetic patients with F3/F4 fibrosis recruited and followed prospectively Receives: Other: blood sampling for diabetics patients with F3/F4 fibrosis |
| Patients with liver disease | Other | Patients with liver disease Receives: Other: blood sampling for patients with liver disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decompensation Test in patients with cirrhosis
The discriminating power of the Decompensation Test will be measured using the C-index
Measured: 48 months after the beginning of the project
HCC Test in patients with cirrhosis
The discriminating power of the HCC Test will be measured using the C-index
Measured: 48 months after the beginning of the project
Secondary outcomes (5)
Quantification of Extracellular vesicles proteins
Number of extracellular vesicles
Measured: 48 months after the beginning of the project
Size of Extracellular vesicles proteins and the experimental repeatability
size of extracellular vesicles in nm
Measured: 48 months after the beginning of the project
3D morphology of extracellular vesicles
size of microvesicles in nm
Measured: 48 months after the beginning of the project
Extracellular vesicles plasma concentrations in the general population
Extracellular vesicles concentration per mL
Measured: 48 months after the beginning of the project
number of patients with extreme values of extracellular vesicles in the general population
Extracellular vesicles concentration per mL
Measured: 48 months after the beginning of the project
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start22 Sep 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 845 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Emmanuel RAUTOU, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185360
- Sponsor's protocol ID
- APHP250409
- Acronym
- LIVER-TRACK
- Status last verified
- Mar 2025
- First submitted
- 26 Aug 2025
- Last updated
- 22 Sep 2025
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Diseases: Extracellular Vesicles as Biomarkers
- ClinicalTrials.gov ID
- NCT07185360
- Acronym / sponsor ID
- LIVER-TRACK / APHP250409
- Conditions
- Liver Diseases
- Keywords
- liver decompensation, extracellular vesicles, hepatocellular carcinoma, cirrhosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 845 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 22 Sep 2025 (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.
Worldwide, cirrhosis is responsible for 2 million deaths per year. Hepatocellular carcinoma (HCC) accounts for 800,000 of these deaths and is the 3rd leading cause of cancer related death. Cirrhosis affects mainly a working age population, hence its heavy economic burden.While patients with compensated cirrhosis do not have symptoms and have a 10-year life expectancy, decompensation of cirrhosis heralds a dramatic decrease in life expectancy to 2 years. Biomarkers allowing reliable estimation of the risk for decompensation of cirrhosis would allow community-based care, possibly by nurse practitioners, of patients at low risk, while patients had high risk could be managed in secondary and tertiary care centers and included in clinical trials. Because HCC is usually asymptomatic at early stages, when it is still curable, it can easily be missed. Biomarkers allowing stratification of the risk of HCC would allow reinforced surveillance (using magnetic resonance imaging) of high-risk patients, and their inclusion in chemoprevention clinical trials.
LIVER-TRACK aims at reliably predicting the outcome of patients with compensated cirrhosis through the development of a Tests for Decompensation and a Test for HCC. This will be achieved through leveraging circulating extracellular vesicles (EVs), an untapped source of biomarkers in liver diseases, as prognostic indicators, and combining them with existing blood biomarkers and single-nucleotide polymorphisms (SNPs). LIVER-TRACK also aims at delivering technologies for EV measurement that are useable in medical practice.
Detailed description
Worldwide, cirrhosis is responsible for 2 million deaths per year. Hepatocellular carcinoma (HCC) accounts for 800,000 of these deaths and is the 3rd leading cause of cancer related death. Cirrhosis affects mainly a working age population, hence its heavy economic burden. While patients with compensated cirrhosis do not have symptoms and have a 10-year life expectancy, decompensation of cirrhosis heralds a dramatic decrease in life expectancy to 2 years. Biomarkers allowing reliable estimation of the risk for decompensation of cirrhosis would allow community-based care, possibly by nurse practitioners, of patients at low risk, while patients had high risk could be managed in secondary and tertiary care centers and included in clinical trials. Because HCC is usually asymptomatic at early stages, when it is still curable, it can easily be missed. Biomarkers allowing stratification of the risk of HCC would allow reinforced surveillance (using magnetic resonance imaging) of high-risk patients, and their inclusion in chemoprevention clinical trials.
LIVER-TRACK aims at reliably predicting the outcome of patients with compensated cirrhosis through the development of a Tests for Decompensation and a Test for HCC. This will be achieved through leveraging circulating extracellular vesicles (EVs), an untapped source of biomarkers in liver diseases, as prognostic indicators, and combining them with existing blood biomarkers and single-nucleotide polymorphisms (SNPs). LIVER-TRACK also aims at delivering technologies for EV measurement that are useable in medical practice.
LIVER-TRACK outputs are expected to: i) improve care for individual patients at highest medical need, i.e., patients with cirrhosis with high risk of decompensation or HCC; ii) decrease cirrhosis burden for public health, iii) facilitate drug development; and iv) technically allow exploitation of EVs as biomarkers in clinical practice, an obligatory step permitting expansion to other fields such as cancer and cardiovascular diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Volunteers without liver disease | Other | Other: blood sampling for volunteersVolunteers without liver disease |
| Diabetic patients with F3/F4 fibrosis recruited and followed prospectively | Other | Other: blood sampling for diabetics patients with F3/F4 fibrosisDiabetic patients with F3/F4 fibrosis recruited and followed prospectively |
| Patients with liver disease | Other | Other: blood sampling for patients with liver diseasePatients with liver disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 18 or over
- Type 2 diabetic (ADA/WHO criteria recalled in section 20.5)
- Hepatic fibrosis stage F3/F4 on liver biopsy or hepatic elasticity > 10 kPa
- Major
- Child-Pugh A, B or C cirrhosis, diagnosed on the basis of histological evidence or liver elasticity > 15 kPa or a combination of biological and radiological signs.
Key exclusion criteria (37 listed)
- Known liver disease
- Active cancer
- Viral or bacterial infection within 2 weeks of inclusion (respiratory, dermatological, urinary, digestive, etc.)
- Transfusion in the month preceding inclusion
- Current participation or less than 3 months' participation in a therapeutic interventional trial
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 |
|---|---|---|
| blood sampling for volunteersA 38.5 ml blood sample will be taken to test for research taken to test for research | Other | Volunteers without liver disease |
| blood sampling for diabetics patients with F3/F4 fibrosis32.5 ml will be sampled at inclusion, at one year visit and two year visit | Other | Diabetic patients with F3/F4 fibrosis recruited and followed prospectively |
| blood sampling for patients with liver diseaseA blood sample of 35.5 mL maximum will be taken for research purposes at the inclusion visit, M1 visit and M3 visit. | Other | Patients with liver disease |
Primary outcome
Decompensation Test in patients with cirrhosis
Time frame: 48 months after the beginning of the project
The discriminating power of the Decompensation Test will be measured using the C-index
HCC Test in patients with cirrhosis
Time frame: 48 months after the beginning of the project
The discriminating power of the HCC Test will be measured using the C-index
5 secondary outcomes
Quantification of Extracellular vesicles proteins
Time frame: 48 months after the beginning of the project
Size of Extracellular vesicles proteins and the experimental repeatability
Time frame: 48 months after the beginning of the project
3D morphology of extracellular vesicles
Time frame: 48 months after the beginning of the project
Extracellular vesicles plasma concentrations in the general population
Time frame: 48 months after the beginning of the project
number of patients with extreme values of extracellular vesicles in the general population
Time frame: 48 months after the beginning of the project
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 22 Sep 2025.
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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.
Pierre Emmanuel RAUTOU principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling for volunteers, blood sampling for diabetics patients with F3/F4 fibrosis and blood sampling for patients with liver disease in people with Liver Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 37 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: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Pierre Emmanuel RAUTOU (+33 1 40 87 52 83, pierre-emmanuel.rautou@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decompensation Test in patients with cirrhosis (time frame: 48 months after the beginning of the project). The study lists 2 primary outcomes in all. 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 22 Sep 2025.