protocolSection identificationModule nctId: NCT06318949, orgStudyIdInfo id: 87RI22_0007 (MALAHBAR), briefTitle: Albumin Modifications as Early Biomarkers of Chronic Liver Diseases, acronym: MALAHBAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-06-01, completionDateStruct date: 2029-12-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University Hospital, Limoges, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective multicentre study of biomarker validation, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 756, type: ESTIMATED, armsInterventionsModule interventions name: blood sampling, outcomesModule primaryOutcomes measure: Ability of HSA PTM to predict the evolution of liver damage at 3 year in patients with an advanced chronic liver disease (ACLD) as recently defined in the BAVENO VII recommendations based on FibroScan., secondaryOutcomes measure: ability of post-translational HSA modifications to predict the evolution of liver damage at 3 years based on liver-related events or on the worsening of the disease stage evaluated by the de Child Pugh or MELD score., secondaryOutcomes measure: ability of the different isoforms of HSA to predict the evolution of liver damage at 1 and 2 years provided that data are available in the medical file., secondaryOutcomes measure: ability of SEB test to predict the evolution of liver damage at 3 years (and at 1 and 2 years provided data are available in the medical file)., secondaryOutcomes measure: diagnostic performances of the SEB test and of the different isoforms of HSA at each stage of the liver disease., secondaryOutcomes measure: confirm that the isoforms of HAS present in the characteristic patterns (type of isoform and intensity) of the nature of the liver damage., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Angers Univeristy Hospital, city: Angers, zip: 49100, country: France, contacts name: Jerome BOURSIER, MD, role: CONTACT, email: JeBoursier@chu-angers.fr, contacts name: Jerome BOURSIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.46667, lon: -0.55, locations facility: Limoges University Hospital, city: Limoges, zip: 87042, country: France, contacts name: Souleiman EL BALKHI, MD, role: CONTACT, email: Souleiman.ElBalkhi@chu-limoges.fr, contacts name: Paul CARRIER, MD, role: CONTACT, email: Paul.Carrier@chu-limoges.fr, contacts name: Paul CARRIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Poitiers University Hospital, city: Poitiers, zip: 86000, country: France, contacts name: Valentin ROLLE, MD, role: CONTACT, email: v.rolle@chu-poitiers.fr, contacts name: Valentin ROLLE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Rennes University Hospital, city: Rennes, zip: 35000, country: France, contacts name: Florent ARTRU, MD, role: CONTACT, email: florent.artru@chu-rennes.fr, contacts name: Florent ARTRU, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Tours University Hospital, city: Tours, zip: 37170, country: France, contacts name: Laure ELKRIEF, MD, role: CONTACT, email: l.elkrief@chu-tours.fr, contacts name: Laure ELKRIEF, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.38333, lon: 0.68333, locations facility: Pointe à Pitre University Hospital, city: Pointe-a-Pitre, zip: 97159, country: Guadeloupe, contacts name: Moana GELU-SIMEON, role: CONTACT, email: moana.simeon@chu-guadeloupe.fr, contacts name: Moana GELU-SIMEON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 16.24125, lon: -61.53614, hasResults: False