Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-03 @ 8:13 PM
Study NCT ID:
NCT06855056
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 189}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To test the prognostic accuracy of novel biomarkers identified within the DECISION project.', 'timeFrame': 'Until September 30th 2025', 'description': 'The primary objective will be evaluated assessing the following end-point:\n\n● Survival at 3 months'}], 'secondaryOutcomes': [{'measure': 'To characterize the clinical and biological features at the time of discharge predicting the 6-month outcome and the different trajectories of patients surviving a hospitalization for AD complicated or not by ACLF.', 'timeFrame': 'Until September 30th 2025', 'description': 'Secondary objectives will be evaluated assessing the following end-points:\n\n* Survival at 6 months\n* Incidence of emergent re-admissions to hospital at 3 months due to liver related causes\n* Incidence of emergent re-admissions to hospital at 6 months due to liver related causes\n* Incidence of emergent re-admissions to hospital at 3 months due to non liver related causes\n* Incidence of emergent re-admissions to hospital at 6 months due to non liver related causes\n* Incidence of ACLF at 3 months\n* Incidence of ACLF at 6 months\n* Incidence of TIPS insertion at 3 months\n* Incidence of TIPS insertion at 6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Decompensated Liver Cirrhosis', 'Acute on Chronic Liver Failure (ACLF)', 'Liver Diseases', 'Liver Cirrhosis', 'Biomarkers'], 'conditions': ['Liver Cirrhosis', 'Decompensated Cirrhosis of Liver']}, 'descriptionModule': {'briefSummary': 'The study aims to test the effectiveness of new biomarkers (measurable molecules in our body) in predicting the health outcome of patients with liver cirrhosis discharged from the hospital after a serious complication of the disease', 'detailedDescription': 'The PROSPECT study is part of the larger EU H2020 DECISION project, which aims to analyze and clarify the pathophysiological mechanisms of decompensated cirrhosis at the systemic level and its transition to ACLF, with the goal of significantly reducing mortality through therapies tailored to the specific needs of individual patients or patient groups.\n\nAs planned in the DECISION project, the biological samples of three large cohorts of patients with cirrhosis admitted to hospital for acute decompensation (AD) without ACLF, deriving from the EF-CLIF-promoted observational studies CANONIC and PREDICT (Europe) and ACLARA (South America) were analyzed to measure lipidomics, epigenomics, whole-blood transcriptomics, micro-RNA, serum metabolomics, plasma cytokines, and plasma extracellular vesicles.\n\nBoth system medicine approaches and more traditional methods of analysis have been applied to analyze and interpret the results. The analyses are still ongoing due to the very high number of variables and the complexity of associating -omics to clinical data, yet, some of these analyses have already generated solid data allowing the identification of novel biomarkers which can be further tested.\n\nIn the PROSPECT study, patients hospitalized for acute decompensation of liver cirrhosis, who meet the inclusion and exclusion criteria, will be enrolled after providing signed informed consent. Participants will be screened and included in the study within 48 hours prior to the expected discharge from the hospital. The study will last 180 days and will include an initial visit during which clinical parameters and additional blood samples will be collected, followed by two follow-up visits - which can also be conducted by phone - during which only clinical information will be gathered. Samples will be analyzed to determine the biomarkers selected within the DECISION project and parameters related to the following pathophysiological mechanisms:\n\n* systemic inflammation\n* blood and microRNA transcriptome\n* the metabolomic landscape\n* albumin structure and function\n* coagulation assays\n* extracellular vesicles\n* endothelial function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients eligible for this study will be patients with decompensated cirrhosis expected to be discharged from the hospital within 48 hours after an index admission for AD according to the EASL-CLIF criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 80 years.\n2. Patients with decompensated cirrhosis admitted to hospital due to AD according to the EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portal hypertensive- related gastrointestinal bleeding, bacterial infection, or any combination of these), including those who presented ACLF during hospitalization.\n3. Recovery from AD and expected to be discharged within the next 48 hours.\n\nExclusion Criteria:\n\n1. Admission for planned diagnostic or therapeutic procedures\n2. Active malignancy (except for hepatocellular carcinoma within the Milan criteria or nonmelanocytic skin cancer)\n3. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months.\n4. HIV positive (except undergoing treatment and who do not exhibit clinical manifestations of AIDS).\n5. Ongoing alcohol use disorder with an expected low adherence to prescriptions as judged by physician\n6. Previous liver or other organ transplantation\n7. Patients with TIPS or other surgical porto-caval shunts\n8. Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate \\<20 ml/min according to the MDRD equations\n9. Chronic heart failure NYHA class III or IV\n10. Pulmonary disease GOLD III or IV\n11. Patients with a history of significant extrahepatic disease with life expectancy \\<6 months\n12. Severe psychiatric disorders\n13. Pregnancy and breast-feeding\n14. Expected low adherence to study protocol as judged by physician\n15. Patients who cannot provide written informed consent or refuse to participate'}, 'identificationModule': {'nctId': 'NCT06855056', 'acronym': 'PROSPECT', 'briefTitle': 'Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'European Foundation for Study of Chronic Liver Failure'}, 'officialTitle': 'Validation of New Prognostic biomarkerRs in Patients With cirrhOsis diScharged After a hosPitalization Due to acutE deCompensation or acuTe-on-chronic Liver Failure', 'orgStudyIdInfo': {'id': 'PROSPECT'}, 'secondaryIdInfos': [{'id': '847949', 'type': 'OTHER_GRANT', 'domain': 'European Health and Digital Executive Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Decompensated Liver Cirrhosis', 'description': 'Patients eligible for this study will be patients with decompensated cirrhosis expected to be discharged from the hospital within 48 hours after an index admission for AD according to the EASL-CLIF criteria'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92110', 'city': 'Clichy', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Emmanuel Rautou, PI', 'role': 'CONTACT', 'email': 'perautou@yahoo.fr'}, {'name': 'Pierre-Emmanuel Rautou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '52074', 'city': 'Aachen', 'state': 'Germany', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tony Bruns', 'role': 'CONTACT', 'email': 'tbruns@ukaachen.de'}, {'name': 'Tony Bruns', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital, Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '48149', 'city': 'Münster', 'state': 'Germany', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jonel Trebicka', 'role': 'CONTACT', 'email': 'Jonel.Trebicka@ukmuenster.de'}, {'name': 'Jonel Trebicka', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Italia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Caraceni', 'role': 'CONTACT', 'email': 'paolo.caraceni@unibo.it'}, {'name': 'Paolo Caraceni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di S.Orsola', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '10126', 'city': 'Torino', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Alessandria', 'role': 'CONTACT', 'email': 'carloalessandria@libero.it'}, {'name': 'Carlo Alessandria', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Città della Salute e della Scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Spain', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan Genescà', 'role': 'CONTACT', 'email': 'joan.genesca@vallhebron.cat'}, {'name': 'Joan Genescà', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hospital Universitari Vall d'Hebron Research Institute", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Spain', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Fernandez', 'role': 'CONTACT', 'email': 'JFDEZ@clinic.cat'}, {'name': 'Javier Fernandez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Spain', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Agustin Albillos', 'role': 'CONTACT', 'email': 'agustin.albillos@uah.es'}, {'name': 'Agustin Albillos', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'NW3 2QG', 'city': 'London', 'state': 'United Kingdom', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Raj Mookerjee', 'role': 'CONTACT', 'email': 'r.mookerjee@ucl.ac.uk'}, {'name': 'Raj Mookerjee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Anna Bosch', 'role': 'CONTACT', 'email': 'anna.bosch@efclif.com', 'phone': '+34 93 227 14 03'}, {'name': 'Cristina Sánchez-Garrido', 'role': 'CONTACT', 'email': 'cristina.sanchez@efclif.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Foundation for Study of Chronic Liver Failure', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universität Münster', 'class': 'OTHER'}, {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, {'name': 'Hospital Clinic de Barcelona, Barcelona, Spain', 'class': 'UNKNOWN'}, {'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, {'name': 'Beaujon Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Aachen', 'class': 'OTHER'}, {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}