Clinical trial NCT06802731: LivQ-box® Parameters in the Diagnosis of Liver Inflammation
Official title: A Multicenter Study on the Application of LivQ-box® Parameters in the Diagnosis of Liver Inflammation in Patients with Non-alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Inflammation
Fatty Liver Disease
Lead sponsor: Wuxi Hisky Medical Technology Co Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tsinghua Changgeng Hospital
First posted: 2025-01-31
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases

Brief summary: To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.

Detailed description: This study is a multi-center study that retrospectively analyzed and prospectively included 240 NAFLD patients in total who met the inclusion criteria. The laboratory, iLivTouch, and liver biopsy results were collected to evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels. In the end, cut-off values for different stages of inflammation were obtained.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases;
* Age over 18 years old, gender not limited;
* Not combined with liver diseases (such as viral hepatitis, drug-induced liver injury, autoimmune liver disease);
* Perform iLivTouch examination within ± 14 days of liver pathology examination;
* No history of excessive alcohol consumption (converted to ethanol:\<140g/week for males,\<70g/week for females);

Primary outcomes:
measure: Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University
state: Beijing
Study officials:
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