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Open AccessArticle

An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials

Department of Anatomical Pathology, Singapore General Hospital, Singapore 169856, Singapore
Duke-NUS Medical School, National University of Singapore, Singapore 169857, Singapore
Department of Pathology, Beaujon Hospital Paris Diderot University, 92110 Clichy, France
Peking University People’s Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing International Cooperation Base for Science and Technology on NAFLD Diagnosis, Beijing 100044, China
Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing 100084, China
Institute for Precision Medicine, Tsinghua University, Beijing 100084, China
HistoIndex Pte. Ltd., Singapore 139955, Singapore
Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore 169608, Singapore
Department of Pathology, National University Hospital, Singapore 119074, Singapore
Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117597, Singapore
Author to whom correspondence should be addressed.
Diagnostics 2020, 10(9), 643;
Received: 20 July 2020 / Revised: 22 August 2020 / Accepted: 24 August 2020 / Published: 28 August 2020
(This article belongs to the Special Issue Fatty Liver Disease: Diagnostic, Predictive and Prognostic Markers)
Background: Many clinical trials with potential drug treatment options for non-alcoholic fatty liver disease (NAFLD) are focused on patients with non-alcoholic steatohepatitis (NASH) stages 2 and 3 fibrosis. As the histological features differentiating stage 1 (F1) from stage 2 (F2) NASH fibrosis are subtle, some patients may be wrongly staged by the in-house pathologist and miss the opportunity for enrollment into clinical trials. We hypothesized that our refined artificial intelligence (AI)-based algorithm (qFibrosis) can identify these subtle differences and serve as an assistive tool for in-house pathologists. Methods: Liver tissue from 160 adult patients with biopsy-proven NASH from Singapore General Hospital (SGH) and Peking University People’s Hospital (PKUH) were used. A consensus read by two expert hepatopathologists was organized. The refined qFibrosis algorithm incorporated the creation of a periportal region that allowed for the increased detection of periportal fibrosis. Consequently, an additional 28 periportal parameters were added, and 28 pre-existing perisinusoidal parameters had altered definitions. Results: Twenty-eight parameters (20 periportal and 8 perisinusoidal) were significantly different between the F1 and F2 cases that prompted a change of stage after a careful consensus read. The discriminatory ability of these parameters was further demonstrated in a comparison between the true F1 and true F2 cases as 26 out of the 28 parameters showed significant differences. These 26 parameters constitute a novel sub-algorithm that could accurately stratify F1 and F2 cases. Conclusion: The refined qFibrosis algorithm incorporated 26 novel parameters that showed a good discriminatory ability for NASH fibrosis stage 1 and 2 cases, representing an invaluable assistive tool for in-house pathologists when screening patients for NASH clinical trials. View Full-Text
Keywords: NAFLD; NASH fibrosis; qFibrosis NAFLD; NASH fibrosis; qFibrosis
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MDPI and ACS Style

Leow, W.-Q.; Bedossa, P.; Liu, F.; Wei, L.; Lim, K.-H.; Wan, W.-K.; Ren, Y.; Chang, J.P.-E.; Tan, C.-K.; Wee, A.; Goh, G.B.-B. An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials. Diagnostics 2020, 10, 643.

AMA Style

Leow W-Q, Bedossa P, Liu F, Wei L, Lim K-H, Wan W-K, Ren Y, Chang JP-E, Tan C-K, Wee A, Goh GB-B. An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials. Diagnostics. 2020; 10(9):643.

Chicago/Turabian Style

Leow, Wei-Qiang; Bedossa, Pierre; Liu, Feng; Wei, Lai; Lim, Kiat-Hon; Wan, Wei-Keat; Ren, Yayun; Chang, Jason P.-E.; Tan, Chee-Kiat; Wee, Aileen; Goh, George B.-B. 2020. "An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials" Diagnostics 10, no. 9: 643.

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