MD, clinical assistant
Katrine Tholstrup Bech
Centre for Liver Research, Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 01.12.2024 | |
| Slut | 30.06.2025 | |
Evaluation of a population-based screening strategy for chronic liver disease
Short summary
We will use a blood-based algorithm, LiverRisk Score (LRS), to screen adults from the general population for liver fibrosis. People with a positive screening will be further investigated with transient elastography. A small sample with negative LRS will serve as controls. The study will be implemented in four hospital centers across Europe (Odense, Barcelona, Hannover, Zagreb). Each protocol has been adapted according to country-specific conditions, with individual ethical approvals sought.
Rationale
Liver cirrhosis is widely prevalent and is associated with high morbidity and mortality. Liver fibrosis progression occurs silently until severe complications occur being responsible for multiple hospitalizations, poor quality of life, and high mortality. At these late stages, cirrhosis is irreversible and survival is dependent on liver transplantation, which unfortunately is not feasible in all patients and not available everywhere. In contrast, early detection allows prevention and personalized treatment when the disease is still reversible. Conventional blood-based liver tests have poor sensitivity and specificity for identifying cirrhosis, whereas newer generations of cheap and widely available blod-based algorithms have increased diagnostic accuracy. Among these is the (c)LiverRisk Score (LRS), which predicts the degree of liver stiffness (LSM, an accurate surrogate for liver fibrosis) and future liver-related outcomes in an adult general population without known liver disease. LRS has been developed and validated from general population cohorts including more than 14,000 participants and is both cheap and widely available. Study aim: to evaluate LRS as a tool for population-based screening for liver fibrosis; to compare the diagnostic performance of LRS with other blood-based tools; to study the prognostic performance of the screening strategy.
Description of the cohort
Approximately 8000 participants from the general population, included from four centres across Europe: - Odense University Hospital, Department of Gastroenterology and Hepatology - Liver Unit, Hospital Clinic, IDIBAPS, University of Barcelona, Spain - Hannover Medical School, Hannover, Germany - Department of Gastroenterology, Hepatology and Clinical Nutrition, University Hospital Dubrava, Zagreb, Croatia
Data and biological material
- Clinical data (medical history, objective measures) - Questionnaires (demography, risk factors, AUDIT, self-reported health and QoL) - Blood samples - Data from the patient journal and national registries (CPR registry, National Patient Registry, Diagnosis and Cancer Registry, Cause of death, National prescription database, Blood-sample registry) - Ultrasound examination - Liver stiffness measurements by Transient Elastography
Collaborating researchers and departments
Liver Unit, Hospital Clinic, IDIBAPS, University of Barcelona, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd), Spain
- Pere Ginés, MD, Professor
- Adria Juanola, MD, PhD
- Ruth Nadal, Research nurse
Hannover Medical School, Hannover, Germany
- Frank Lammert, MD, Professor
Department of Gastroenterology, Hepatology and Clinical Nutrition, University Hospital Dubrava, University of Zagreb School of Medicine and Faculty of Pharmacy and Biochemistry, Zagreb, Croatia
- Ivica Grgurevic, MD, Professor
Center for Liver Research, Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark
- Maja Thiele, MD, Professor
- Peter Andersen, Data manager
- Helle Lindholm Schnefeld, Research nurse
Publications associated with the project