Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation

Detalhes bibliográficos
Autor(a) principal: Gonçalves-Reis, Maria
Data de Publicação: 2024
Outros Autores: Proença, Daniela, Frazão, Laura P., Neto, João L., Silva, Sílvia, Pinto-Marques, Hugo, Pereira-Leal, José B., Cardoso, Joana
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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spelling 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
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