Liver Diseases: Extracellular Vesicles as Biomarkers
LIVER-TRACK
1 other identifier
interventional
845
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2025
CompletedFirst Posted
Study publicly available on registry
September 22, 2025
CompletedStudy Start
First participant enrolled
September 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
September 22, 2025
March 1, 2025
2.2 years
August 26, 2025
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Decompensation Test in patients with cirrhosis
The discriminating power of the Decompensation Test will be measured using the C-index
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
48 months after the beginning of the project
Secondary Outcomes (5)
Quantification of Extracellular vesicles proteins
48 months after the beginning of the project
Size of Extracellular vesicles proteins and the experimental repeatability
48 months after the beginning of the project
3D morphology of extracellular vesicles
48 months after the beginning of the project
Extracellular vesicles plasma concentrations in the general population
48 months after the beginning of the project
number of patients with extreme values of extracellular vesicles in the general population
48 months after the beginning of the project
Study Arms (3)
Volunteers without liver disease
OTHERVolunteers without liver disease
Diabetic patients with F3/F4 fibrosis recruited and followed prospectively
OTHERDiabetic patients with F3/F4 fibrosis recruited and followed prospectively
Patients with liver disease
OTHERPatients with liver disease
Interventions
A 38.5 ml blood sample will be taken to test for research taken to test for research
32.5 ml will be sampled at inclusion, at one year visit and two year visit
A blood sample of 35.5 mL maximum will be taken for research purposes at the inclusion visit, M1 visit and M3 visit.
Eligibility Criteria
You may not qualify if:
- Known liver disease
- Active cancer
- Current participation or less than 3 months' participation in a therapeutic interventional trial
- Absence of signed informed consent
- Not affiliated to a social security scheme
- Pregnant women
- Person under guardianship or trusteeship
- Diabetic patients with F3/F4 fibrosis recruited and followed prospectively
- 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
- 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
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bichat Hospital, Beaujon Hospital, Cochin Hospital and Lariboisière Hospital
Paris, France, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Emmanuel RAUTOU
APHP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2025
First Posted
September 22, 2025
Study Start
September 22, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
September 22, 2025
Record last verified: 2025-03