NCT07185360Not yet recruiting
Liver Diseases: Extracellular Vesicles as Biomarkers
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 845 (estimated)
- First submitted
- 26 Aug 2025
- Start date
- 22 Sept 2025
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07185360
What you commit to
- Study type: Interventional
- Planned participants: 845
- From 22 Sept 2025 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known liver disease
- Active cancer
- Viral or bacterial infection within 2 weeks of inclusion (respiratory, dermatological, urinary, digestive, etc.)
- 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:
- 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 :
Other
- Transfusion in the month preceding inclusion
- 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
- Protected adult
- Not affiliated to or not benefiting from a social security scheme
- Pregnant or breast-feeding women
- Absence of signed informed consent
- 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
Who the study is looking for
- 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.
Criteria the registry did not label
- Volunteers without liver disease
- \- Inclusion criteria: Major
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bichat Hospital, Beaujon Hospital, Cochin Hospital and Lariboisière Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.