Fatty Liver Disease Collaborative Research in China

NCT ID: NCT02391168

Last Updated: 2015-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Fatty Liver Fatty Liver, Alcoholic Non-alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unimed Scientific Inc.

INDUSTRY

Sponsor Role collaborator

Fatty Liver and Alcoholic Liver Disease Study Group, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiangao Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Zhangzhou Zhengxing Hospital

Zhangzhou, Fujian, China

Site Status NOT_YET_RECRUITING

Shandong Provincial Hospital

Ji'nan, Shandong, China

Site Status NOT_YET_RECRUITING

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status NOT_YET_RECRUITING

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Shanghai Xinhua Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiangao Fan, MD

Role: CONTACT

Chao Sun, MD

Role: CONTACT

Facility Contacts

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Ruidan Zheng, MD

Role: primary

Wanhua Ren, MD

Role: primary

Yuqiang Mi, MD

Role: primary

Fangping He, MD

Role: primary

Junping Shi, MD

Role: primary

Jiangao Fan, MD

Role: primary

Other Identifiers

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FLD2015

Identifier Type: -

Identifier Source: org_study_id

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