Natural history of NASH and HCC.
Francesco Negro
https://pubmed.ncbi.nlm.nih.gov/32077608Actively Recruiting
Age: 18Years +
All Genders
ID06802731
A Multicenter Study on the Application of LivQ-box® Parameters in Diagnosing Liver Inflammation in Patients with Non-alcoholic Fatty Liver Disease
Led by Wuxi Hisky Medical Technology Co Ltd · Updated on 2025-01-31
365
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
W
Wuxi Hisky Medical Technology Co Ltd
Lead Sponsor
B
Beijing Tsinghua Changgeng Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the relationship between LivQ-box® parameters carried by the iLivTouch device and liver inflammation in patients with non-alcoholic fatty liver disease (NAFLD). This multicenter study includes both retrospective and prospective analysis of 240 NAFLD patients to assess how these parameters correlate with the severity of liver inflammation and to develop diagnostic cut-off values for different inflammation stages. The study collects laboratory data, iLivTouch measurements, and liver biopsy results from participants. The iLivTouch examination is performed within 14 days of the liver pathology exam to evaluate LivQ-box® parameters. This observational research aims to determine the diagnostic value of these parameters for various levels of liver inflammation severity in NAFLD patients. Participants undergo assessments including the iLivTouch examination and liver biopsy, along with laboratory tests. Researchers analyze the correlation between LivQ-box® parameters and liver inflammation, focusing on diagnostic accuracy and establishing cut-off values. The primary outcome measure is evaluated over 12 months, providing insights into the use of iLivTouch technology in diagnosing liver inflammation in NAFLD.
CONDITIONS
Brief Title
LivQ-box® Parameters in the Diagnosis of Liver Inflammation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with NAFLD according to the American Association for the Study of Liver Diseases guidance
- Age over 18 years old
- Both genders eligible
- No other liver diseases such as viral hepatitis, drug-induced liver injury, or autoimmune liver disease
- iLivTouch examination performed within ±14 days of liver pathology examination
- No history of excessive alcohol consumption (less than 140g/week for males, less than 70g/week for females)
You will not qualify if you...
- Presence of other liver diseases (viral hepatitis, drug-induced liver injury, autoimmune liver disease)
- History of excessive alcohol consumption (equal to or above 140g/week for males, equal to or above 70g/week for females)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Within 14 days around liver pathology examination
Participants undergo iLivTouch examination and liver biopsy to assess liver inflammation.
1 to 2 visits depending on diagnostic procedures
Long-term Monitoring
Duration - 12 months
Participants are observed to evaluate the correlation and diagnostic performance of LivQ-box parameters over 12 months.
Periodic assessments during the 12-month observation
Trial Site Locations
Total: 1 location
1
Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
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Research Team
L
Lai Wei
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Epidemiological Features of NAFLD From 1999 to 2018 in China.
Jianghua Zhou, Feng Zhou, Wenxin Wang...
https://pubmed.ncbi.nlm.nih.gov/32012320Prevalence of Liver Steatosis and Fibrosis in the General Population and Various High-Risk Populations: A Nationwide Study With 5.7 Million Adults in China.
Sailimai Man, Yuhan Deng, Yuan Ma...
https://pubmed.ncbi.nlm.nih.gov/37380136Clinical features of hepatocellular carcinoma associated with nonalcoholic fatty liver disease: a review of human studies.
Kohei Oda, Hirofumi Uto, Seiichi Mawatari...
https://pubmed.ncbi.nlm.nih.gov/25575848Nonalcoholic fatty liver disease: a systematic review.
Mary E Rinella
https://pubmed.ncbi.nlm.nih.gov/26057287Risks and clinical predictors of cirrhosis and hepatocellular carcinoma diagnoses in adults with diagnosed NAFLD: real-world study of 18 million patients in four European cohorts.
Myriam Alexander, A Katrina Loomis, Johan van der Lei...
https://pubmed.ncbi.nlm.nih.gov/31104631Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030.
Chris Estes, Quentin M Anstee, Maria Teresa Arias-Loste...
https://pubmed.ncbi.nlm.nih.gov/29886156Metabolic and histological features of non-alcoholic fatty liver disease patients with different serum alanine aminotransferase levels.
V W-S Wong, G L-H Wong, S W-C Tsang...
https://pubmed.ncbi.nlm.nih.gov/19035982Prevalence of clinically significant liver disease within the general population, as defined by non-invasive markers of liver fibrosis: a systematic review.
Rebecca Harris, David J Harman, Timothy R Card...
https://pubmed.ncbi.nlm.nih.gov/28404158A novel quantitative ultrasound technique for identifying non-alcoholic steatohepatitis.
Feng Gao, Qiong He, Gang Li...
https://pubmed.ncbi.nlm.nih.gov/34564946