Fatty Liver Disease Collaborative Research in China (FLDCR)

August 3, 2015 updated by: Fatty Liver and Alcoholic Liver Disease Study Group, China

A Multi-center, Prospective Cohort Study on the Natural History of Fatty Liver Disease in China

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Zhangzhou, Fujian, China
        • Not yet recruiting
        • Zhangzhou Zhengxing Hospital
        • Contact:
          • Ruidan Zheng, MD
        • Principal Investigator:
          • Ruidan Zheng, MD
    • Shandong
      • Ji'nan, Shandong, China
        • Not yet recruiting
        • Shandong Provincial Hospital
        • Principal Investigator:
          • Wanhua Ren, MD
    • Tianjin
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Tianjin Second People's Hospital
        • Contact:
          • Yuqiang Mi, MD
        • Principal Investigator:
          • Yuqiang Mi, MD
    • Xinjiang
      • Urumqi, Xinjiang, China
        • Not yet recruiting
        • The first affiliated hospital of Xinjiang Medical University
        • Contact:
          • Fangping He, MD
        • Principal Investigator:
          • Fangping He, MD
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The Affiliated Hospital of Hangzhou Normal University
        • Principal Investigator:
          • Junping Shi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

any person with fatty liver disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
liver cirrhosis
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
liver cancer
Time Frame: 5 years
5 years
liver failure
Time Frame: 5 years
5 years
type 2 diabetes
Time Frame: 5 years
5 years
cardiovascular and cerebrovascular events
Time Frame: 5 years
5 years
death
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatty Liver and Alcoholic Liver Disease Study Group, China

Collaborators

Unimed Scientific Inc.

Investigators

  • Principal Investigator: Jiangao Fan, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLD2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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