NCT02391168Unknown不适用
A Multi-center, Prospective Cohort Study on the Natural History of Fatty Liver Disease in China
Fatty Liver and Alcoholic Liver Disease Study Group, China6 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2015年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 6
- 主要终点
- liver cirrhosis
研究概览
简要总结
A multi-center, prospective cohort study on the natural history of fatty liver disease in China
详细描述
This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with liver biopsy-proven macrovesicular steatosis (>5%) will be enrolled in the baseline cross-sectional analysis. Those who are either diagnosed as NAFLD or ALD, if meeting all the inclusion and exclusion criteria, will be enrolled in the following cohort study, will be followed up after 1 year, 3 years and 5 years with a visit window of +1 month.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed fatty liver disease, confirmed by liver biopsy.
- •Specific biopsy requirements: qualified biopsy specimen within 6 months, >5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.
- •Only patients with NAFLD or ALD are eligible for the 5-year follow-up cohort study.
- •Willing to participate in the long-term follow-up and cooperative.
- •Able to provide informed consent file.
排除标准
- •Unable to provide informed consent.
- •Patients are eligible for baseline cross-sectional analysis but not eligible for the cohort section, if having any of the following condition:
- •Any end-stage liver disease.
- •Any malignant tumor.
- •Any infection of hepatitis virus or HIV.
- •Any congenital liver disease such as Wilson disease.
- •Any other serious disease of projected survival < 5 years.
- •Combined NAFLD and ALD.
结局指标
主要结局
liver cirrhosis
时间窗: 5 years
次要结局
- liver cancer(5 years)
- type 2 diabetes(5 years)
- liver failure(5 years)
- death(5 years)
- cardiovascular and cerebrovascular events(5 years)
研究者
研究点 (6)
Loading locations...
相似试验
招募中
不适用
A Study to Identify the Risk of Non-alcoholic Fatty Liver Disease (NAFLD) in Patients With Type 2 Diabetes in Clinical Practice and to Evaluate the Clinical Usefulness of Dapagliflozin/Pioglitazone Combination TherapyType 2 DiabetesNCT06649162Boryung Pharmaceutical Co., Ltd10,000
招募中
不适用
A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Liver CancerHepatitisLiver CancerLiver CirrhosisFatty LiverNCT05719480Nanfang Hospital, Southern Medical University2,000
Unknown
不适用
Fatty Liver in PregnancyFatty LiverNCT00471575Assaf-Harofeh Medical Center
招募中
不适用
Prospective cohort study on liver disease-related tumor markers (DCP, NX-DCP, and NX-DCP-R) in patients with hepatitis C, cirrhosis, and hepatocellular carcinoma-influence by severe alcoholicsJPRN-UMIN000014264Kobe University Hospital700
Unknown
不适用
Evaluation of an Endoscopic Sutured Gastroplasty in Patients With NonAlcoholic Steatohepatitis (NASH) and Fibrosis.NASH - Nonalcoholic SteatohepatitisNCT04653311Erasme University Hospital100