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)
Prediction of Risk of Hepatic Decompensation and Hepatocellular Carcinoma in Advanced Fibrotic or Cirrhotic Patients With Chronic Hepatitis C After Sustained Virologic Response
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Bangkok
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Bangkok、Bangkok、泰国、10700
- Siriraj Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Development of de novo hepatocellular carcinoma
大体时间: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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Predictive accuracy of the FIB-4 score for de novo hepatocellular carcinoma
大体时间: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
大体时间: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
大体时间: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 ALBI 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 aMAP score for de novo hepatocellular carcinoma
大体时间: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.
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At 1, 3, 5, and 8 years after SVR12
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合作者和调查者
调查人员
- 首席研究员:Tawesak Tanwandee, MD、Siriraj Hospital
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 984-2566-IRB1
- Si 034/2024 (其他标识符:Siriraj Institutional Review Board, Faculty of Medicine Siriraj Hospital, Mahidol University)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
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