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Open AccessArticle

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

1
Department of Anatomical Pathology, Singapore General Hospital, Singapore 169856, Singapore
2
Duke-NUS Medical School, National University of Singapore, Singapore 169857, Singapore
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Department of Pathology, Beaujon Hospital Paris Diderot University, 92110 Clichy, France
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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
5
Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing 100084, China
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Institute for Precision Medicine, Tsinghua University, Beijing 100084, China
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HistoIndex Pte. Ltd., Singapore 139955, Singapore
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Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore 169608, Singapore
9
Department of Pathology, National University Hospital, Singapore 119074, Singapore
10
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; https://doi.org/10.3390/diagnostics10090643
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. https://doi.org/10.3390/diagnostics10090643

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. https://doi.org/10.3390/diagnostics10090643

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. https://doi.org/10.3390/diagnostics10090643

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