Microvesicles and Monocytes to Predict Mortality of Patients with Cirrhosis
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- France5 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 335 people enrolled
- Started
- 12 Jun 2019
- Ended
- 29 Feb 2024
- Type of study
- Observational
- Record updated
- 20 December 2024
Who can take part
- Age
- 18 years to 90 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Age between 18 and 90 years
- Child-Pugh B or Child-Pugh C cirrhosis diagnosed on the basis of one or several of the following elements :; Liver Biopsy; Liver stiffness>15kPa measured by Fibroscan; Combination of clinical, laboratory and imaging criteria characteristic of cirrhosis (association of signs of portal hypertension, liver failure and abnormal liver morphology in a patient with at least one cause of cirrhosis)
Who cannot take part
- Digestive bleeding within 15 days before inclusion
- Alcoholic hepatitis in the previous month
- Hepatocellular carcinoma outside the Milan criteria contraindicating transplantation
- History of porto-systemic shunt or liver transplant
- Budd-Chiari Syndrome
- HIV or known immune deficiency or immunosuppressive treatment
- Acute renal failure (increase in serum creatinin level by more than 1.5 times the baseline value or by more than 26 μmol/l from the baseline value) within 15 days before inclusion
- Bacterial infection proven or highly suspected on the basis of clinical-laboratory features within 15 days of inclusion
- Primary sclerosing cholangitis
- Primary biliary cirrhosis
- Active extrahepatic neoplasia
- Pregnant or breastfeeding woman
- Protected populations: persons under guardianship or curatorship
- Patient not affiliated to social security
- Patient who did not signed consent
- Ongoing participation in an intervention research whose protocol could, according to the literature, modify the release of hepatocyte microvesicles or the IFN score
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Chronic liver diseases related to viral hepatitis, metabolic syndrome or excessive alcohol consumption can evolve towards cirrhosis. Cirrhosis is responsible for 170 000 deaths per year in Europe. Initially asymptomatic and called "compensated" it can become "decompensated" with the developement of acute complications such as infections, ascites or variceal bleeding. The transition from compensated to decompensated cirrhosis is associated with a reduction in survival from 95 to 55% at 1 year.
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The only curative treatment for cirrhosis is liver transplantation (LT). Liver transplants are allocated according to the severity of the patients. Despite a modest prognostic value (area under the ROC curve = 0.7 to predict the risk of death), graft allocation is based on the MELD (Model for End-Stage Liver Disease) score including INR, bilirubin and serum creatinine. In 2014, 11.5% of registered patients died on the liver transplant waiting list, illustrating the need for biomarkers that predict death and improve MELD-based prediction.
Microvesicles are membrane vesicles released in extracellular space during cell activation or apoptosis. Our team showed that circulating levels of hepatocyte microvesicles increase with the severity of cirrhosis and predict survival at 6 months independently of MELD score in a cohort of 242 patients with cirrhosis.
Type 1 interferons (IFN-1) are mediators of inflammation, which is excessively activated in cirrhosis. Our team has shown that a gene signature (IFN score) measured in the immune cells of 101 patients with cirrhosis is able to predict 6 month-survival independently of the MELD score.
Thus, the investigators hypothesize that a composite score combining the level of circulating hepatocyte microvesicles, the IFN score and the MELD score could improve the prediction of survival in patients with severe cirrhosis.
The aim of this study is to compare the prognostic performance for the cumulative incidence of death at 6 months of a composite score including MELD, hepatocyte microvesicle level and IFN score with that of the MELD score alone, in patients with Child B or C cirrhosis, considering liver transplantation as a competitive risk.
To address this question, peripheral blood from 335 patients with Child B or C cirrhosis will be obtained and hepatocyte microvesicle levels and IFN score will be measured using ELISA/filtration and Real Time-quantitative PCR.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 20 December 2024