An interventional study of blood sampling for volunteers and blood sampling for diabetics patients with F3/F4 fibrosis in Liver Diseases, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Basic science
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.
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 845 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Volunteers without liver disease
- Inclusion criteria: Major
Exclusion Criteria:
Diabetic patients with F3/F4 fibrosis recruited and followed prospectively
Inclusion criteria:
Exclusion criteria:
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.
Illness linked to other etiologies:
Patients with liver disease :
Inclusion criteria:
Exclusion criteria:
Volunteers without liver disease
Other: blood sampling for volunteers
Diabetic patients with F3/F4 fibrosis recruited and followed prospectively
Other: blood sampling for diabetics patients with F3/F4 fibrosis
Patients with liver disease
Other: blood sampling for patients with liver disease
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.
Decompensation Test in patients with cirrhosis
The discriminating power of the Decompensation Test will be measured using the C-index
Time frame: 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
Time frame: 48 months after the beginning of the project
Quantification of Extracellular vesicles proteins
Number of extracellular vesicles
Time frame: 48 months after the beginning of the project
Size of Extracellular vesicles proteins and the experimental repeatability
size of extracellular vesicles in nm
Time frame: 48 months after the beginning of the project
3D morphology of extracellular vesicles
size of microvesicles in nm
Time frame: 48 months after the beginning of the project
Extracellular vesicles plasma concentrations in the general population
Extracellular vesicles concentration per mL
Time frame: 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
Time frame: 48 months after the beginning of the project
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris