跳至主要内容
临床试验/NCT05560997
NCT05560997招募中不适用

Machine Learning to Identify Metabolic Subtypes of Non-Alcoholic Fatty Liver Disease

Yan Bi1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
histological cirrhosis checklist

研究概览

简要总结

The purpose of this study was to use machine learning to explore a more precise classification of NAFLD subgroups towards informing individualized therapy.

详细描述

Clinical characteristics of NAFLD are heterogenous, but current classification for diagnosis is simply based on pathological examination. The conventional pathological classification is insufficient to reflect the complexity and heterogeneity of NAFLD and can not predict the prognosis. Towards precision treatment, a more refined metabolic classification of NAFLD phenotypes is highly demanded for a personalized diagnosis, aiming to identify patients at elevated risk of cardiovascular disease or cirrhosis. This kind of refined classification can provide a more precise diagnosis and enable more individualized preventive interventions and early treatments. In a cross-sectional cohort, unsupervised machine learning was used to cluster patients with biopsy-proved NAFLD from Drum Tower Hospital Affiliated to Nanjing University Medical School based on clinical variables. Verification of the clustering was performed in a longitudinal cohort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • biopsy-proved NALD cohort:
  • age 18 to 75 years
  • receiving liver biopsy at the time of metabolic surgery
  • relatively complete clinical information, including physical examination, biochemical and haematological assessments
  • longitudinal cohort
  • age 18 to 75 years
  • receiving abdominal imaging examinations,
  • relatively complete clinical information, including physical examination, biochemical and haematological assessments (4)follow-up time at least more than 12 months

排除标准

  • (1)consumed excessive alcohol (≥140 g/week for males or ≥ 70 g/week for females) •
  • (2) with history of other liver diseases including chronic hepatitis, biliary obstructive diseases or autoimmune hepatitis

结局指标

主要结局

histological cirrhosis checklist

时间窗: up to 5 years

cirrhosis was defined as widespread disruption of normal liver structure by the formation of pseudolobules or Scheuer stage 4 fibrosis in pathological findings.

Ischemic heart disease

时间窗: up to 5 years

Objective Findings of Coronary Stenosis (≥ 50%) in at least 2 coronary artery territories (ie, left anterior descending, ramus intermedius, left circumflex, right coronary artery) involving the vain vessel, a major branch, or a bypass graft

Documented heart disease checklist

时间窗: up to 5 years

Documented Myocardial Infarction or Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting

hepatocellular carcinoma

时间窗: up to 5 years

the diagnosis of hepatocellular carcinoma was based on well-established diagnostic imaging criteria and/or histology.

次要结局

未报告次要终点

研究者

发起方
Yan Bi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yan Bi

Chief Physician

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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