NCT05532345已完成不适用
Development and Validation of a Machine Learning Model to Differentiate Drug-induced Liver Injury and Autoimmune Hepatitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,583
- 试验地点
- 1
- 主要终点
- Accuracy of the model in the differential diagnosis of DILI and AIH
研究概览
简要总结
A retrospective, multi-center, non-interventional cohort study has been going to explore whether artificial intelligence can discriminate Drug-induced liver injury and Autoimmune hepatitis.
A machine learning-based tool will be developed and validated to help clinicians to differentiate between Drug-induced liver injury and Autoimmune hepatitis
详细描述
Research Objectives:
- To develop a machine learning-based model from retrospective data.
- To validate the machine learning-based model from internal dataset and external datasets nationwide.
- To setup a website or application based on the above model to discriminate Drug-induced liver injury and Autoimmune hepatitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug-induced liver injury
- •RUCAM ≥6 and met one of the following biochemical conditions: a.) ALT≥5 ULN, b.) or ALP ≥2 ULN, iii) or ALT≥3 ULN and TBil≥2 ULN.
- •RUCAM was between 3-5, the medical records were further reviewed by the three authors to determine the eligibility.
- •Autoimmune hepatitis
- •The revised International Autoimmune Hepatitis Group (IAIHG) diagnostic score≥6 points.
- •Liver biopsy available, which is compatible with typical features of AIH.
- •If liver biopsy was unavailable, patients who achieved biochemical resolution after sustained immunosuppressive therapy.
排除标准
- •Drug-induced liver injury
- •Hepatotropic viral infection: hepatitis A, B, C, D and E.
- •Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
- •Hypoxic ischemic hepatitis and congestive liver disease.
- •Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
- •Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
- •Autoimmune hepatitis.
- •Parasitic infection.
- •Previous liver transplantation or bone marrow transplantation.
- •Pregnancy or lactation.
- •Genetic and metabolic liver diseases.
- •Autoimmune hepatitis
- •Hepatotropic viral infection: hepatitis A, B, C, D and E.
- •Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
- •Hypoxic ischemic hepatitis and congestive liver disease.
- •Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
- •Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
- •Drug-induced liver injury.
- •Parasitic infection.
- •Previous liver transplantation or bone marrow transplantation.
- •Pregnancy or lactation.
- •Genetic and metabolic liver diseases.
结局指标
主要结局
Accuracy of the model in the differential diagnosis of DILI and AIH
时间窗: May 31, 2023
The ratio of the correct number of forecasts to the total number of forecasts
The confidence of the model in the differential diagnosis of DILI and AIH
时间窗: May 31, 2023
The confidence and 95% confidence internal of the model in determining whether each case is DILI or AIH
次要结局
未报告次要终点
研究者
研究点 (1)
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