Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT02391168
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02391168
Study Brief:
Protocol Section:
NCT02391168