Using albumin modifications to identify early signs of chronic liver disease
Albumin Modifications as Early Biomarkers of Chronic Liver Diseases
This study is testing if changes in a protein called albumin in the blood can help spot early signs of chronic liver disease in people who may already have liver damage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 756 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 7 sites (Angers and 6 other locations) |
| Trial ID | NCT06318949 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the use of albumin post-translational modifications as early biomarkers for chronic liver disease (CLD). By analyzing serum albumin isoforms, the researchers hypothesize that these modifications can indicate early hepatocellular damage and predict future liver disease progression. The study involves blood sampling from participants who meet specific criteria, including those with compensated fibrosis. The goal is to develop a non-invasive and sensitive diagnostic tool to improve early detection and management of liver diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with compensated fibrosis as determined by hepatic elasticity measurements.
Not a fit: Patients with decompensated cirrhosis, advanced renal failure, or certain cancers are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier diagnosis and better management of chronic liver diseases, potentially reducing mortality rates.
How similar studies have performed: While there have been studies exploring biomarkers for liver disease, the specific use of albumin modifications as predictive indicators is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Angers and 6 other locations
- Angers Univeristy Hospital — Angers, France (Recruiting)
- Limoges University Hospital — Limoges, France (Recruiting)
- Poitiers University Hospital — Poitiers, France (Recruiting)
- Rennes University Hospital — Rennes, France (Recruiting)
- Toulouse University Hospital — Toulouse, France (Recruiting)
- Tours University Hospital — Tours, France (Not_yet_recruiting)
- Pointe à Pitre University Hospital — Pointe-à-Pitre, Guadeloupe (Not_yet_recruiting)
Study contacts
- Study coordinator: Souleiman EL BALKHI, MD
- Email: Souleiman.ElBalkhi@chu-limoges.fr
- Phone: 0555058035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.