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Recruiting NCT06802731

LivQ-box® Parameters in the Diagnosis of Liver Inflammation

— Observational Liver Inflammation Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Liver Inflammation, Fatty Liver Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Primary outcome measures

  • Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch. [Time frame: 12 months]

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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University — Beijing

Publications

  • Negro F. Natural history of NASH and HCC. Liver Int. 2020 Feb;40 Suppl 1:72-76. doi: 10.1111/liv.14362. PMID 32077608
  • 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
  • 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
  • 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
  • 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
  • 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/ PMID 31104631
  • 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, Ita PMID 29886156
  • 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

Identifiers

NCT: NCT06802731 · HSKE-LI001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗