Clinical trial NCT02391168: Fatty Liver Disease Collaborative Research in China
Official title: A Multi-center, Prospective Cohort Study on the Natural History of Fatty Liver Disease in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fatty Liver
Fatty Liver, Alcoholic
Non-alcoholic Fatty Liver Disease
Lead sponsor: Fatty Liver and Alcoholic Liver Disease Study Group, China
Sponsor class: OTHER
Collaborators: name: Unimed Scientific Inc.
First posted: 2015-03-18
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any person with fatty liver disease

Brief summary: A multi-center, prospective cohort study on the natural history of fatty liver disease in China

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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:

  1. Any end-stage liver disease.
  2. Any malignant tumor.
  3. Any infection of hepatitis virus or HIV.
  4. Any congenital liver disease such as Wilson disease.
  5. Any other serious disease of projected survival \< 5 years.
  6. Combined NAFLD and ALD.

Primary outcomes:
measure: liver cirrhosis
timeFrame: 5 years
Secondary outcomes:
measure: liver cancer
timeFrame: 5 years
measure: liver failure
timeFrame: 5 years
measure: type 2 diabetes
timeFrame: 5 years
measure: cardiovascular and cerebrovascular events
timeFrame: 5 years
measure: death
timeFrame: 5 years
Other outcomes:
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Zhengxing Hospital
state: Fujian
city: Ji'nan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
state: Tianjin
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai Xinhua Hospital
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Jiangao Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: