- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04677101
Liquid Biopsy for NASH and Liver Fibrosis (LIBRA)
Liquid Biopsy as a Non-invasive Tool for the Diagnosis of NASH and Liver Fibrosis
Nonalcoholic fatty liver disease (NAFLD) has evolved to represent the most common cause of chronic liver disease globally. Today, NAFLD is a leading indication for liver transplantation and a major etiology for hepatocellular carcinoma (HCC) in the United States. NAFLD is characterized by the excess accumulation of lipids within the liver and ranges from isolated steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by the presence of hepatic necroinflammation, hepatocyte ballooning and fibrosis progression.
Currently, liver biopsy remains the gold standard for the diagnosis of various chronic liver diseases, and for determining the severity of liver injury, inflammation, and fibrosis stage. However, this procedure is invasive, prone to complications such as bleeding and is associated with sampling variability and limited representation of the whole liver. Other limitations include, the difficulty to monitor liver injury progression over time and underestimation of disease severity.
Despite intensive research, currently available non-invasive blood tests are not sufficiently sensitive or specific and are therefore of limited use. Blood biomarkers might provide significant advances in the diagnosis and monitoring of disease progression and regression in clinical settings.
Recently, liquid biopsy has emerged as a potential, less invasive, alternative to liver biopsy. In fact, it addresses several unmet clinical needs, including sensitivity, specificity, the determination of prognoses, and the prediction of therapeutic responses.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This is a multicentric prospective observational study to validate blood non-invasive biomarkers for NASH and fibrosis stage.
150 subjects will be enrolled; 100 subjects with biopsy-proven NASH and 50 subjects with normal liver will be used as controls.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Roma, Italia
- University of Rome Sapienza
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Rome, Italia, 00168
- Catholic University School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
One hundred subjects with NASH documented by liver biopsy and no evidence of another form of liver disease with a BMI ≥30 and ≤55 kg/m2.
Fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls.
Descripción
Inclusion Criteria:
One hundred subjects with NASH documented by liver biopsy and no evidence of another form of liver disease with a BMI ≥30 and ≤55 kg/m2.
Fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls.
Exclusion Criteria:
Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 6 months; Liver cirrhosis; End stage renal failure; Participation in any other concurrent therapeutic clinical trial; Any other life-threatening, non-cardiac disease; Pregnancy; Inability to give informed consent; Substantial alcohol consumption (>20 g/day for women or >30 g/day for men); Wilson's disease; Lipodystrophy; Parenteral nutrition; Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Subjects with NASH documented by liver biopsy
One hundred subjects with NASH documented by liver biopsy and no evidence of another form of liver disease with a BMI ≥30 and ≤55 kg/m2.
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Fine-needle liver biopsy
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Healhy Donor
Fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls.
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Fine-needle liver biopsy
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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The primary aim of our study is to validate blood non-invasivebiomarker sensitivity and accuracy in predicting NASH and fibrosis stage.
Periodo de tiempo: 2 months
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2 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20201612
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre EHNA - Esteatohepatitis no alcohólica
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Visirna Therapeutics HK LimitedAún no reclutando
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Hadassah Medical OrganizationRetirado
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Institute of Liver and Biliary Sciences, IndiaRetiradoCirrosis descompensada relacionada con NASHIndia
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Zhejiang Medicine Co., Ltd.The Affiliated Hospital of Hangzhou Normal University; R&G Pharma Studies Co....TerminadoNASH (esteatohepatitis no alcohólica)Porcelana
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Akero Therapeutics, IncReclutamientoNASH/PURÉ | NAFLD/MASLDEstados Unidos, Canadá, Puerto Rico, Australia, India, Israel, Suiza, Reino Unido
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Jeffrey BrowningNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)TerminadoSaludable | NASH (esteatohepatitis no alcohólica) | NAFLD (enfermedad del hígado graso no alcohólico)Estados Unidos
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Vanderbilt University Medical CenterTerminadoEnfermedades del HIGADO | Cirrosis hepática | NASH (esteatohepatitis no alcohólica)Estados Unidos
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Seoul St. Mary's HospitalGlaxoSmithKlineTerminadoNASH (Esteato-hepatitis no alcohólica)
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Assiut UniversityAún no reclutando
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Columbia UniversityPfizerRetiradoNASH (esteatohepatitis no alcohólica) | NAFLD (enfermedad del hígado graso no alcohólico)
Ensayos clínicos sobre Liver Biopsy
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Aquyre Bioscience, IncBoston University; Fox Chase Cancer Center; Johnson & JohnsonReclutamiento
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University Hospital, Basel, SwitzerlandTerminadoBiopsia de Médula ÓseaSuiza
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Transplant Genomics, Inc.Aún no reclutandoRechazo de trasplante de hígado
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Cliniques universitaires Saint-Luc- Université...Université de LiègeReclutamientoFibrosis quística | BiomarcadoresBélgica
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Northwestern UniversityReclutamientoFragilidad | Cirrosis | Trasplante de hígadoEstados Unidos
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Samsung Medical CenterDesconocido
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Robert J. PorteKing's College Hospital NHS Trust; Universitaire Ziekenhuizen KU Leuven; Erasmus... y otros colaboradoresTerminadoEnfermedad hepática en etapa terminal | Insuficiencia hepática | Enfermedades del Tracto BiliarPaíses Bajos, Bélgica, Reino Unido