Actively Recruiting
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
7
Research Sites
26 weeks
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants who undergo routine care are observed. Blood samples and medical data are collected during usual care visits to assess albumin modifications as early biomarkers of liver disease progression.
Visits at inclusion and at 1, 2, and 3 years during routine care
Trial Site Locations
Total: 7 locations
1
Angers Univeristy Hospital
Angers, France, 49100
Actively Recruiting
2
Limoges University Hospital
Limoges, France, 87042
Actively Recruiting
3
Poitiers University Hospital
Poitiers, France, 86000
Actively Recruiting
4
Rennes University Hospital
Rennes, France, 35000
Actively Recruiting
5
Toulouse University Hospital
Toulouse, France, 31400
Actively Recruiting
6
Tours University Hospital
Tours, France, 37170
Not Yet Recruiting
7
Pointe à Pitre University Hospital
Pointe-à-Pitre, Guadeloupe, 97159
Not Yet Recruiting
Research Team
S
Souleiman EL BALKHI, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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