Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation
Autor(a) principal: | |
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Data de Publicação: | 2024 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10362/163817 |
Resumo: | Funding Information: The authors wish to thank to the European Innovation Council for having partially financed this work with a grant under the EIC Accelerator scheme (Contract Nº946364). The authors also thank the patients, Neuralshift, and the pathology team from the Curry Cabral Hospital headed by António Figueiredo, with a special mention to Clara Rodrigues. Moreover, the authors particularly acknowledge the Biobank IRBLleida (PT20/00021) integrated in the Spanish National Biobanks Network and Xarxa de Bancs de Tumors de Catalunya sponsored by Pla Director d’Oncología Catalunya ( XBTC ), as well as the Biobank ISABIAL integrated in the Spanish National Biobanks Network and in the Valencia Biobanking Network for their collaboration. Funding Information: This work was supported by the EU EIC Innovation Council ( EIC accelerator grant GA No 946364). Funding Information: Samples: In this study, HCC samples preserved as FFPE tissue were used. FFPE HCC samples were acquired from four different suppliers: Biobank IRBLleida (PT20/00021), integrated in the Spanish National Biobanks Network and Xarxa de Bancs de Tumors de Catalunya (XBTC) sponsored by Pla Director d'Oncología de Catalunya; Biobank ISABIAL, integrated in the Spanish National Biobanks Network and in the Valencian Biobanking Network; and biorepositories from Amsbio (US) and Biotech (US). All samples were processed following standard operating procedures with the appropriate approval of the Ethical and Scientific Committees. Moreover, clinical samples from a retrospective clinical study approved by the ethics authorities and taking place in the Curry Cabral Hospital (Lisbon, Portugal), were also used. All HCC FFPE samples were acquired either sectioned with 3–5 μm thickness or as paraffin blocks that were then cut in 3–5 μm thick slices using a microtome (Leica SM2010R Sliding Microtome, Leica Biosystems) and mounted on a glass slide.This work was supported by the EU EIC Innovation Council (EIC accelerator grant GA No 946364).The authors wish to thank to the European Innovation Council for having partially financed this work with a grant under the EIC Accelerator scheme (Contract Nº946364). The authors also thank the patients, Neuralshift, and the pathology team from the Curry Cabral Hospital headed by António Figueiredo, with a special mention to Clara Rodrigues. Moreover, the authors particularly acknowledge the Biobank IRBLleida (PT20/00021) integrated in the Spanish National Biobanks Network and Xarxa de Bancs de Tumors de Catalunya sponsored by Pla Director d'Oncología Catalunya (XBTC), as well as the Biobank ISABIAL integrated in the Spanish National Biobanks Network and in the Valencia Biobanking Network for their collaboration. Publisher Copyright: © 2024 Ophiomics |
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Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantationAnalytical validationHepatocellular carcinomaHepatoPredictLiver transplantationMulti-target genomic assayPrognosticRadiological and Ultrasound TechnologyClinical BiochemistryFunding Information: The authors wish to thank to the European Innovation Council for having partially financed this work with a grant under the EIC Accelerator scheme (Contract Nº946364). The authors also thank the patients, Neuralshift, and the pathology team from the Curry Cabral Hospital headed by António Figueiredo, with a special mention to Clara Rodrigues. Moreover, the authors particularly acknowledge the Biobank IRBLleida (PT20/00021) integrated in the Spanish National Biobanks Network and Xarxa de Bancs de Tumors de Catalunya sponsored by Pla Director d’Oncología Catalunya ( XBTC ), as well as the Biobank ISABIAL integrated in the Spanish National Biobanks Network and in the Valencia Biobanking Network for their collaboration. Funding Information: This work was supported by the EU EIC Innovation Council ( EIC accelerator grant GA No 946364). Funding Information: Samples: In this study, HCC samples preserved as FFPE tissue were used. FFPE HCC samples were acquired from four different suppliers: Biobank IRBLleida (PT20/00021), integrated in the Spanish National Biobanks Network and Xarxa de Bancs de Tumors de Catalunya (XBTC) sponsored by Pla Director d'Oncología de Catalunya; Biobank ISABIAL, integrated in the Spanish National Biobanks Network and in the Valencian Biobanking Network; and biorepositories from Amsbio (US) and Biotech (US). All samples were processed following standard operating procedures with the appropriate approval of the Ethical and Scientific Committees. Moreover, clinical samples from a retrospective clinical study approved by the ethics authorities and taking place in the Curry Cabral Hospital (Lisbon, Portugal), were also used. All HCC FFPE samples were acquired either sectioned with 3–5 μm thickness or as paraffin blocks that were then cut in 3–5 μm thick slices using a microtome (Leica SM2010R Sliding Microtome, Leica Biosystems) and mounted on a glass slide.This work was supported by the EU EIC Innovation Council (EIC accelerator grant GA No 946364).The authors wish to thank to the European Innovation Council for having partially financed this work with a grant under the EIC Accelerator scheme (Contract Nº946364). The authors also thank the patients, Neuralshift, and the pathology team from the Curry Cabral Hospital headed by António Figueiredo, with a special mention to Clara Rodrigues. Moreover, the authors particularly acknowledge the Biobank IRBLleida (PT20/00021) integrated in the Spanish National Biobanks Network and Xarxa de Bancs de Tumors de Catalunya sponsored by Pla Director d'Oncología Catalunya (XBTC), as well as the Biobank ISABIAL integrated in the Spanish National Biobanks Network and in the Valencia Biobanking Network for their collaboration. Publisher Copyright: © 2024 OphiomicsObjectives: To verify the analytical performance of the HepatoPredict kit, a novel tool developed to stratify Hepatocellular Carcinoma (HCC) patients according to their risk of relapse after a Liver Transplantation (LT). Methods: The HepatoPredict tool combines clinical variables and a gene expression signature in an ensemble of machine-learning algorithms to forecast the benefit of a LT in HCC patients. To ensure the accuracy and reliability of this method, extensive analytical validation was conducted to verify its specificity and robustness. The experiments were designed following the guidelines for multi-target genomic assays such as ISO201395-2019, MIQE, CLSI-MM16, CLSI-MM17, and CLSI-EP17-A. The validation process included reproducibility between operators and between RNA extractions and RT-qPCR runs, and interference of input RNA levels or varying reagent levels. A recently retrained version of the HepatoPredict algorithms was also tested. Results: The validation process demonstrated that the HepatoPredict kit met the required standards for robustness (p > 0.05), analytical specificity (inclusivity of 95 %), and sensitivity (LoB, LoD, linear range, and amplification efficiency between 90 and 110 %). The operator, equipment, input RNA, and reagents used had no significant effect on the HepatoPredict results. Additionally, the testing of a recently retrained version of the HepatoPredict algorithm, showed that this new version further improved the accuracy of the kit and performed better than existing clinical criteria in accurately identifying HCC patients who are more likely to benefit LT. Conclusions: Even with the introduced variations in molecular and clinical variables, the HepatoPredict kit's prognostic information remains consistent. It can accurately identify HCC patients who are more likely to benefit from a LT. Its robust performance also confirms that it can be easily integrated into standard diagnostic laboratories.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNGonçalves-Reis, MariaProença, DanielaFrazão, Laura P.Neto, João L.Silva, SílviaPinto-Marques, HugoPereira-Leal, José B.Cardoso, Joana2024-02-20T00:04:48Z2024-032024-03-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/163817eng2352-5517PURE: 83652624https://doi.org/10.1016/j.plabm.2024.e00365info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:49:06Zoai:run.unl.pt:10362/163817Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:59:52.802528Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation |
title |
Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation |
spellingShingle |
Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation Gonçalves-Reis, Maria Analytical validation Hepatocellular carcinoma HepatoPredict Liver transplantation Multi-target genomic assay Prognostic Radiological and Ultrasound Technology Clinical Biochemistry |
title_short |
Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation |
title_full |
Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation |
title_fullStr |
Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation |
title_full_unstemmed |
Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation |
title_sort |
Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation |
author |
Gonçalves-Reis, Maria |
author_facet |
Gonçalves-Reis, Maria Proença, Daniela Frazão, Laura P. Neto, João L. Silva, Sílvia Pinto-Marques, Hugo Pereira-Leal, José B. Cardoso, Joana |
author_role |
author |
author2 |
Proença, Daniela Frazão, Laura P. Neto, João L. Silva, Sílvia Pinto-Marques, Hugo Pereira-Leal, José B. Cardoso, Joana |
author2_role |
author author author author author author author |
dc.contributor.none.fl_str_mv |
NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) RUN |
dc.contributor.author.fl_str_mv |
Gonçalves-Reis, Maria Proença, Daniela Frazão, Laura P. Neto, João L. Silva, Sílvia Pinto-Marques, Hugo Pereira-Leal, José B. Cardoso, Joana |
dc.subject.por.fl_str_mv |
Analytical validation Hepatocellular carcinoma HepatoPredict Liver transplantation Multi-target genomic assay Prognostic Radiological and Ultrasound Technology Clinical Biochemistry |
topic |
Analytical validation Hepatocellular carcinoma HepatoPredict Liver transplantation Multi-target genomic assay Prognostic Radiological and Ultrasound Technology Clinical Biochemistry |
description |
Funding Information: The authors wish to thank to the European Innovation Council for having partially financed this work with a grant under the EIC Accelerator scheme (Contract Nº946364). The authors also thank the patients, Neuralshift, and the pathology team from the Curry Cabral Hospital headed by António Figueiredo, with a special mention to Clara Rodrigues. Moreover, the authors particularly acknowledge the Biobank IRBLleida (PT20/00021) integrated in the Spanish National Biobanks Network and Xarxa de Bancs de Tumors de Catalunya sponsored by Pla Director d’Oncología Catalunya ( XBTC ), as well as the Biobank ISABIAL integrated in the Spanish National Biobanks Network and in the Valencia Biobanking Network for their collaboration. Funding Information: This work was supported by the EU EIC Innovation Council ( EIC accelerator grant GA No 946364). Funding Information: Samples: In this study, HCC samples preserved as FFPE tissue were used. FFPE HCC samples were acquired from four different suppliers: Biobank IRBLleida (PT20/00021), integrated in the Spanish National Biobanks Network and Xarxa de Bancs de Tumors de Catalunya (XBTC) sponsored by Pla Director d'Oncología de Catalunya; Biobank ISABIAL, integrated in the Spanish National Biobanks Network and in the Valencian Biobanking Network; and biorepositories from Amsbio (US) and Biotech (US). All samples were processed following standard operating procedures with the appropriate approval of the Ethical and Scientific Committees. Moreover, clinical samples from a retrospective clinical study approved by the ethics authorities and taking place in the Curry Cabral Hospital (Lisbon, Portugal), were also used. All HCC FFPE samples were acquired either sectioned with 3–5 μm thickness or as paraffin blocks that were then cut in 3–5 μm thick slices using a microtome (Leica SM2010R Sliding Microtome, Leica Biosystems) and mounted on a glass slide.This work was supported by the EU EIC Innovation Council (EIC accelerator grant GA No 946364).The authors wish to thank to the European Innovation Council for having partially financed this work with a grant under the EIC Accelerator scheme (Contract Nº946364). The authors also thank the patients, Neuralshift, and the pathology team from the Curry Cabral Hospital headed by António Figueiredo, with a special mention to Clara Rodrigues. Moreover, the authors particularly acknowledge the Biobank IRBLleida (PT20/00021) integrated in the Spanish National Biobanks Network and Xarxa de Bancs de Tumors de Catalunya sponsored by Pla Director d'Oncología Catalunya (XBTC), as well as the Biobank ISABIAL integrated in the Spanish National Biobanks Network and in the Valencia Biobanking Network for their collaboration. Publisher Copyright: © 2024 Ophiomics |
publishDate |
2024 |
dc.date.none.fl_str_mv |
2024-02-20T00:04:48Z 2024-03 2024-03-01T00:00:00Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10362/163817 |
url |
http://hdl.handle.net/10362/163817 |
dc.language.iso.fl_str_mv |
eng |
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eng |
dc.relation.none.fl_str_mv |
2352-5517 PURE: 83652624 https://doi.org/10.1016/j.plabm.2024.e00365 |
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info:eu-repo/semantics/openAccess |
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openAccess |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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