Liver Diseases: Extracellular Vesicles as Biomarkers
Condition(s) studied
Investigational drug(s) / intervention(s)
blood sampling for volunteers: 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 fibrosis: 32.5 ml will be sampled at inclusion, at one year visit and two year visit
blood sampling for patients with liver disease: A blood sample of 35.5 mL maximum will be taken for research purposes at the inclusion visit, M1 visit and M3 visit.
Study 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.
Eligibility
Primary outcome measure(s)
- Decompensation Test in patients with cirrhosis — 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 — 48 months after the beginning of the project
The discriminating power of the HCC Test will be measured using the C-index
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Bichat Hospital, Beaujon Hospital, Cochin Hospital and Lariboisière Hospital | Paris | France |
More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07185360 on ClinicalTrials.gov ↗ ← All trials in France