Non-Invasive Risk Stratification for Hepatocellular Carcinoma in HCV-Related Compensated Advanced Chronic Liver Disease Following Sustained Virological Response: Validation of the aMAP Score (HCV-aMAP)
1 juillet 2026 mis à jour par: Tawesak Tanwandee, Siriraj Hospital
Prediction of Risk of Hepatic Decompensation and Hepatocellular Carcinoma in Advanced Fibrotic or Cirrhotic Patients With Chronic Hepatitis C After Sustained Virologic Response
This retrospective cohort study evaluated the performance of non-invasive risk scores for predicting de novo hepatocellular carcinoma in adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response after sofosbuvir-based direct-acting antiviral therapy.
Patients treated at Siriraj Hospital between 2013 and 2023 were included if they had compensated advanced chronic liver disease and documented SVR12.
The study compared FIB-4, APRI, ALBI, and aMAP scores calculated at SVR12 for prediction of hepatocellular carcinoma during long-term follow-up.
The primary aim was to identify a very-low-risk subgroup in whom hepatocellular carcinoma surveillance might potentially be de-escalated.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This was a single-center retrospective cohort study conducted at Siriraj Hospital, Thailand. Consecutive adult patients with chronic hepatitis C virus infection and compensated advanced chronic liver disease who initiated interferon-free sofosbuvir-based direct-acting antiviral therapy between 2013 and 2023 and achieved sustained virological response at 12 weeks after treatment completion were included. Compensated advanced chronic liver disease was defined according to Baveno VII criteria, including histologic F3/F4 fibrosis, vibration-controlled transient elastography greater than 10 kPa, or clinical evidence of portal hypertension.
Baseline demographic, clinical, laboratory, and transient elastography data were collected from electronic medical records. The FIB-4, APRI, ALBI, and aMAP scores were calculated using laboratory values at SVR12. Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy, failure to achieve SVR12, or incomplete medical records precluding outcome assessment were excluded.
The primary outcome was de novo hepatocellular carcinoma during follow-up. Predictive performance of the non-invasive scores was assessed using time-to-event analysis, Kaplan-Meier methods, Cox proportional hazards regression, and time-dependent receiver operating characteristic curves at 1, 3, 5, and 8 years.
Type d'étude
Observationnel
Inscription (Réel)
571
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Bangkok
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Bangkok, Bangkok, Thaïlande, 10700
- Siriraj Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Adult patients with chronic hepatitis C virus infection and compensated advanced chronic liver disease who initiated sofosbuvir-based direct-acting antiviral therapy at Siriraj Hospital between 2013 and 2023 and achieved sustained virological response at 12 weeks after treatment completion.
La description
Inclusion Criteria:
- Age 18 years or older
- Chronic hepatitis C virus infection treated with direct-acting antiviral therapy
- Documented sustained virological response at 12 weeks after treatment completion
- Evidence of compensated advanced chronic liver disease before direct-acting antiviral therapy, defined by at least one of the following: histologic F3 or F4 fibrosis, vibration-controlled transient elastography >10 kPa, radiologic features compatible with advanced fibrosis or cirrhosis, or clinical or endoscopic evidence of portal hypertension
- Minimum follow-up of 12 months after sustained virological response
Exclusion Criteria:
- Incomplete or missing medical records precluding outcome assessment
- Known or suspected hepatocellular carcinoma before initiating direct-acting antiviral therapy
- Failure to achieve sustained virological response at 12 weeks
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
HCV-related cACLD After SVR
Adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response at 12 weeks after sofosbuvir-based direct-acting antiviral therapy and were followed for de novo hepatocellular carcinoma.
|
FIB-4, APRI, ALBI, and aMAP scores were calculated using laboratory values at SVR12 to evaluate their performance for predicting de novo hepatocellular carcinoma during follow-up.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Development of de novo hepatocellular carcinoma
Délai: From SVR12 until diagnosis of hepatocellular carcinoma, last follow-up, or up to 8 years after SVR12.
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Occurrence of newly diagnosed hepatocellular carcinoma after achievement of sustained virological response (SVR12).
Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy were excluded.
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From SVR12 until diagnosis of hepatocellular carcinoma, last follow-up, or up to 8 years after SVR12.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Predictive accuracy of the FIB-4 score for de novo hepatocellular carcinoma
Délai: At 1, 3, 5, and 8 years after SVR12
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Time-dependent area under the receiver operating characteristic curve (AUC) of the FIB-4 score for predicting de novo hepatocellular carcinoma.
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At 1, 3, 5, and 8 years after SVR12
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Predictive accuracy of the APRI score for de novo hepatocellular carcinoma
Délai: At 1, 3, 5, and 8 years after SVR12
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Time-dependent area under the receiver operating characteristic curve (AUC) of the APRI score for predicting de novo hepatocellular carcinoma.
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At 1, 3, 5, and 8 years after SVR12
|
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Predictive accuracy of the ALBI score for de novo hepatocellular carcinoma
Délai: At 1, 3, 5, and 8 years after SVR12
|
Time-dependent area under the receiver operating characteristic curve (AUC) of the ALBI score for predicting de novo hepatocellular carcinoma.
|
At 1, 3, 5, and 8 years after SVR12
|
|
Predictive accuracy of the aMAP score for de novo hepatocellular carcinoma
Délai: At 1, 3, 5, and 8 years after SVR12
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Time-dependent area under the receiver operating characteristic curve (AUC) of the aMAP score for predicting de novo hepatocellular carcinoma.
|
At 1, 3, 5, and 8 years after SVR12
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Tawesak Tanwandee, MD, Siriraj Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Fan R, Papatheodoridis G, Sun J, Innes H, Toyoda H, Xie Q, Mo S, Sypsa V, Guha IN, Kumada T, Niu J, Dalekos G, Yasuda S, Barnes E, Lian J, Suri V, Idilman R, Barclay ST, Dou X, Berg T, Hayes PC, Flaherty JF, Zhou Y, Zhang Z, Buti M, Hutchinson SJ, Guo Y, Calleja JL, Lin L, Zhao L, Chen Y, Janssen HLA, Zhu C, Shi L, Tang X, Gaggar A, Wei L, Jia J, Irving WL, Johnson PJ, Lampertico P, Hou J. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis. J Hepatol. 2020 Dec;73(6):1368-1378. doi: 10.1016/j.jhep.2020.07.025. Epub 2020 Jul 21.
- de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2013
Achèvement primaire (Réel)
31 juillet 2023
Achèvement de l'étude (Réel)
31 juillet 2023
Dates d'inscription aux études
Première soumission
25 juin 2026
Première soumission répondant aux critères de contrôle qualité
1 juillet 2026
Première publication (Réel)
7 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections transmissibles par le sang
- Tumeurs par site
- Tumeurs
- Infections
- Infections par virus à ARN
- Maladies virales
- Tumeurs par type histologique
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies du foie
- Hépatite, virale, humaine
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs du foie
- Maladies transmissibles
- Carcinome
- Infections à Flaviviridae
- Hépatite
- Carcinome hépatocellulaire
- Hépatite C
Autres numéros d'identification d'étude
- 984-2566-IRB1
- Si 034/2024 (Autre identifiant: Siriraj Institutional Review Board, Faculty of Medicine Siriraj Hospital, Mahidol University)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual participant data underlying the results reported in this study may be made available from the corresponding author upon reasonable request, subject to approval by the investigators and applicable institutional and ethical regulations.
Délai de partage IPD
Beginning after publication of the study results; no fixed end date.
Critères d'accès au partage IPD
Data will be shared with researchers who provide a methodologically sound proposal for purposes consistent with the approved study protocol and applicable ethical regulations.
Requests should be directed to the corresponding author.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .