Status:
NOT_YET_RECRUITING
Liver Diseases: Extracellular Vesicles as Biomarkers
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Liver Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
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 a...
Eligibility Criteria
Inclusion
- Volunteers without liver disease
- \- Inclusion criteria: Major
- Exclusion Criteria:
- 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
- Not affiliated to a social security scheme
- Pregnant women
- Person under guardianship or trusteeship
- Diabetic patients with F3/F4 fibrosis recruited and followed prospectively
- Inclusion criteria:
- 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
- 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.
- 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 :
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
845 Patients enrolled
Trial Details
Trial ID
NCT07185360
Start Date
September 22 2025
End Date
March 31 2028
Last Update
September 22 2025
Active Locations (1)
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1
Bichat Hospital, Beaujon Hospital, Cochin Hospital and Lariboisière Hospital
Paris, France, France