LivQ-box® Parameters in the Diagnosis of Liver Inflammation

NCT06802731 | Recruiting

• 1 other identifier: HSKE-LI001
• Study Type: observational
• Target: 365
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Inflammation; Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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);

Sponsors & Collaborators

• Wuxi Hisky Medical Technology Co Ltd: lead
• Beijing Tsinghua Changgeng Hospital: collaborator

Study Sites (1)

Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University

Beijing, Beijing Municipality, 102218, China

RECRUITING

Related Publications (10)

• Negro F. Natural history of NASH and HCC. Liver Int. 2020 Feb;40 Suppl 1:72-76. doi: 10.1111/liv.14362.

  PMID: 32077608 BACKGROUND

• Zhou J, Zhou F, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Epidemiological Features of NAFLD From 1999 to 2018 in China. Hepatology. 2020 May;71(5):1851-1864. doi: 10.1002/hep.31150.

  PMID: 32012320 BACKGROUND

• Man S, Deng Y, Ma Y, Fu J, Bao H, Yu C, Lv J, Liu H, Wang B, Li L. Prevalence of Liver Steatosis and Fibrosis in the General Population and Various High-Risk Populations: A Nationwide Study With 5.7 Million Adults in China. Gastroenterology. 2023 Oct;165(4):1025-1040. doi: 10.1053/j.gastro.2023.05.053. Epub 2023 Jun 26.

  PMID: 37380136 BACKGROUND

• Oda K, Uto H, Mawatari S, Ido A. Clinical features of hepatocellular carcinoma associated with nonalcoholic fatty liver disease: a review of human studies. Clin J Gastroenterol. 2015 Feb;8(1):1-9. doi: 10.1007/s12328-014-0548-5. Epub 2015 Jan 10.

  PMID: 25575848 BACKGROUND

• Rinella ME. Nonalcoholic fatty liver disease: a systematic review. JAMA. 2015 Jun 9;313(22):2263-73. doi: 10.1001/jama.2015.5370.

  PMID: 26057287 BACKGROUND

• Alexander M, Loomis AK, van der Lei J, Duarte-Salles T, Prieto-Alhambra D, Ansell D, Pasqua A, Lapi F, Rijnbeek P, Mosseveld M, Waterworth DM, Kendrick S, Sattar N, Alazawi W. Risks 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. BMC Med. 2019 May 20;17(1):95. doi: 10.1186/s12916-019-1321-x.

  PMID: 31104631 BACKGROUND

• Estes C, Anstee QM, Arias-Loste MT, Bantel H, Bellentani S, Caballeria J, Colombo M, Craxi A, Crespo J, Day CP, Eguchi Y, Geier A, Kondili LA, Kroy DC, Lazarus JV, Loomba R, Manns MP, Marchesini G, Nakajima A, Negro F, Petta S, Ratziu V, Romero-Gomez M, Sanyal A, Schattenberg JM, Tacke F, Tanaka J, Trautwein C, Wei L, Zeuzem S, Razavi H. Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030. J Hepatol. 2018 Oct;69(4):896-904. doi: 10.1016/j.jhep.2018.05.036. Epub 2018 Jun 8.

  PMID: 29886156 BACKGROUND

• Wong VW, Wong GL, Tsang SW, Hui AY, Chan AW, Choi PC, Chim AM, Chu S, Chan FK, Sung JJ, Chan HL. Metabolic and histological features of non-alcoholic fatty liver disease patients with different serum alanine aminotransferase levels. Aliment Pharmacol Ther. 2009 Feb 15;29(4):387-96. doi: 10.1111/j.1365-2036.2008.03896.x. Epub 2008 Nov 17.

  PMID: 19035982 BACKGROUND

• Harris R, Harman DJ, Card TR, Aithal GP, Guha IN. Prevalence of clinically significant liver disease within the general population, as defined by non-invasive markers of liver fibrosis: a systematic review. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):288-297. doi: 10.1016/S2468-1253(16)30205-9. Epub 2017 Feb 1.

  PMID: 28404158 BACKGROUND

• Gao F, He Q, Li G, Huang OY, Tang LJ, Wang XD, Targher G, Byrne CD, Luo JW, Zheng MH. A novel quantitative ultrasound technique for identifying non-alcoholic steatohepatitis. Liver Int. 2022 Jan;42(1):80-91. doi: 10.1111/liv.15064. Epub 2021 Sep 30.

  PMID: 34564946 BACKGROUND

MeSH Terms

Conditions

Hepatitis; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fatty Liver

Central Study Contacts

Lai Wei

CONTACT

+86 13601281862; weilai@pkuph.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 31, 2025
• Study Start: January 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

CN (1)