What is this study trying to find out about chronic liver disease?

This study is evaluating whether changes in albumin protein can predict liver disease progression over three years. Researchers want to find better early markers of liver damage to improve diagnosis and care. The University Hospital of Limoges is leading this important research.

Who may be eligible for this chronic liver disease clinical trial?

Adults 18 or older with compensated liver fibrosis measured by FibroScan may qualify. People with advanced liver disease, recent albumin infusions, cancer, or severe kidney failure cannot join. Women who are pregnant or not using contraception are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic liver disease clinical trial?

Study-related care, including blood tests and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06318949

Albumin Modifications as Early Biomarkers of Chronic Liver Diseases to Predict Liver Disease Progression

Led by University Hospital, Limoges · Updated on 2025-02-12

756

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Chronic liver diseases affect over 800 million people worldwide and cause about 2 million deaths each year. Early diagnosis and prediction of disease progression remain major challenges, as current blood markers and panel tests lack sensitivity and specificity. This research focuses on albumin post-translational modifications PTM as potential early biomarkers that may indicate future liver damage and help predict disease progression in patients with chronic liver disease. The study will recruit 756 patients with compensated fibrosis from six university hospitals and follow them for up to three years. Blood samples will be taken at the start and during follow-up visits at one, two, and three years, either through additional tubes added to routine samples or using leftover samples. These will be analyzed centrally to assess albumin isoform profiles and ligand-binding capacities using the Serum Enhanced Binding SEB test. Participants will have no extra visits beyond their usual care appointments. Data including blood results and medical records will be collected at each visit. Researchers will evaluate the ability of albumin modifications and the SEB test to predict liver disease progression, monitor changes over time, and confirm characteristic albumin patterns related to liver injury. The study aims to improve liver disease diagnostics and patient care by validating these novel biomarkers.

CONDITIONS

Brief Title

Albumin Modifications as Early Biomarkers of Chronic Liver Diseases

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

At least 18 years old
Have compensated liver fibrosis with hepatic elasticity of 10 kPa or higher measured by FibroScan
Had blood tests at the hospital as part of consultation or hospitalization including usual liver disease parameters
Affiliated with or beneficiary of a social security system
Not opposed to participate after being informed

You will not qualify if you...

Have decompensated cirrhosis or history of decompensated cirrhosis
Received albumin infusion within one month before inclusion visit
Have stage 4 or 5 renal failure (GFR < 29 ml/min/1.73m²)
Have cancer
Are pregnant, breastfeeding, or a woman of childbearing age without effective contraception
Have mental impairment or psychiatric disorder that affects understanding of the study

Research Team

Souleiman EL BALKHI, MD

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