Albumin Modifications as Early Biomarkers of Chronic Liver Diseases

Summary

Chronic liver diseases, affecting over 800 million people worldwide, lead to approximately 2 million annual deaths. The need for early, sensitive diagnostic strategies to prevent disease progression and reduce mortality is still unmet. The traditional serum markers lack sensitivity and specificity, leading to the integration of these biomarkers into panel tests with algorithms or imaging measures. Despite their widespread use, these tests have limitations at an individual level, including an inability to predict disease progression or response to treatment. To address these shortcomings, our project proposes utilizing albumin post-translational modifications (PTM) as a predictive biomarker for liver disease progression. The hypothesis is that albumin modifications occur in the early stages of hepatocellular damage and are indicative of future liver diseases. These modifications can be detected through serum albumin isoform determination, albumin isoforms profiles or the albumin's ligand-binding capacities. Innovatively, the study will use the Serum Enhanced Binding (SEB) test, which identifies reduced ligand-binding capacities, and discusses a second patent for determining a typical isoform profile based on the hepatic injury type. Our preliminary results from animal models and a proof-of-concept studies with patients support this hypotheses. Our previous studies demonstrated also significant differences in albumin isoform profiles in response to different types of hepatic injury and high sensitivity and specificity in the SEB test among cirrhotic patients. The primary objective of the MALAHBAR project is to evaluate the capacity of albumin PTM to predict liver disease progression over three years in chronic liver disease patients. Secondary objectives include assessing the predictive ability of different albumin isoforms and the SEB test for liver disease progression, evaluating diagnostic performances and confirming characteristic albumin isoform profiles related to specific hepatic injuries. The study could represent a significant advancement in liver disease diagnostics and management, offering new insights into the role of albumin in liver pathology.

Eligibility

Inclusion Criteria:

* At least 18 years old
* With a compensated fibrosis defined by an hepatic elasticity ≥10 kPa measured by FibroScan®
* Having had blood test at the hospital as part of a consultation or an hospitalisation at the inclusion including usual parameters for the liver disease follow-up
* Affiliated with or beneficiaries of a social security system
* Not opposed to participate to the study after being informed

Exclusion Criteria:

* Patients suffering from decompensated cirrhosis or with an history of decompensated cirrhosis
* Patients who received an albumin infusion in the month before the inclusion visit
* Patients suffering from stage 4 or 5 renal failure (GFR \< 29 ml/min/1,73m²)
* Patients suffering from cancer
* Pregnant or breastfeeding women or women of childbearing age without effective contraception (based on declaration)
* Patients suffering from impairment of mental faculties or a psychiatric disorder which could interfere with the understanding of the study

Conditions2

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