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Clinical decision support analysis of a microRNA-based thyroid molecular classifier: A real-world, prospective and multicentre validation study

BACKGROUND: The diagnosis of cancer in Bethesda III/IV thyroid nodules is challenging as fine-needle aspiration (FNA) has limitations, and these cases usually require diagnostic surgery. As approximately 77% of these nodules are not malignant, a diagnostic test accurately identifying benign thyroid...

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Autores principales: Santos, Marcos Tadeu, Rodrigues, Bruna Moretto, Shizukuda, Satye, Oliveira, Andrei Félix, Oliveira, Miriane, Figueiredo, David Livingstone Alves, Melo, Giulianno Molina, Silva, Rubens Adão, Fainstein, Claudio, dos Reis, Gerson Felisbino, Corbo, Rossana, Ramos, Helton Estrela, Camacho, Cléber Pinto, Vaisman, Fernanda, Vaisman, Mário
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9254359/
https://www.ncbi.nlm.nih.gov/pubmed/35785619
http://dx.doi.org/10.1016/j.ebiom.2022.104137
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author Santos, Marcos Tadeu
Rodrigues, Bruna Moretto
Shizukuda, Satye
Oliveira, Andrei Félix
Oliveira, Miriane
Figueiredo, David Livingstone Alves
Melo, Giulianno Molina
Silva, Rubens Adão
Fainstein, Claudio
dos Reis, Gerson Felisbino
Corbo, Rossana
Ramos, Helton Estrela
Camacho, Cléber Pinto
Vaisman, Fernanda
Vaisman, Mário
author_facet Santos, Marcos Tadeu
Rodrigues, Bruna Moretto
Shizukuda, Satye
Oliveira, Andrei Félix
Oliveira, Miriane
Figueiredo, David Livingstone Alves
Melo, Giulianno Molina
Silva, Rubens Adão
Fainstein, Claudio
dos Reis, Gerson Felisbino
Corbo, Rossana
Ramos, Helton Estrela
Camacho, Cléber Pinto
Vaisman, Fernanda
Vaisman, Mário
author_sort Santos, Marcos Tadeu
collection PubMed
description BACKGROUND: The diagnosis of cancer in Bethesda III/IV thyroid nodules is challenging as fine-needle aspiration (FNA) has limitations, and these cases usually require diagnostic surgery. As approximately 77% of these nodules are not malignant, a diagnostic test accurately identifying benign thyroid nodules can reduce “potentially unnecessary” surgery rates. We have previously reported the development and validation of a microRNA-based thyroid classifier (mir-THYpe) with high sensitivity and specificity, which could be performed directly from FNA smear slides. We sought to evaluate the performance of this test in real-world clinical routine to support clinical decisions and to reduce surgery rates. METHODS: We designed a real-world, prospective, multicentre study. Molecular tests were performed with FNA samples prepared at 128 cytopathology laboratories. Patients were followed-up from March 2018 until surgery or until March 2020 (patients with no indication for surgery). The final diagnosis of thyroid tissue samples was retrieved from postsurgical anatomopathological reports. FINDINGS: A total of 435 patients (440 nodules) classified as Bethesda III/IV were followed-up. The rate of avoided surgeries was 52·5% for all surgeries and 74·6% for “potentially unnecessary” surgeries. The test achieved 89·3% sensitivity, 81·65% specificity, 66·2% positive predictive value, and 95% negative predictive value. The test supported 92·3% of clinical decisions. INTERPRETATION: The reported data demonstrate that the use of the microRNA-based classifier in the real-world can reduce the rate of thyroid surgeries with robust performance and support clinical decision-making. FUNDING: The São Paulo Research-Foundation (FAPESP) and Onkos.
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spelling pubmed-92543592022-07-06 Clinical decision support analysis of a microRNA-based thyroid molecular classifier: A real-world, prospective and multicentre validation study Santos, Marcos Tadeu Rodrigues, Bruna Moretto Shizukuda, Satye Oliveira, Andrei Félix Oliveira, Miriane Figueiredo, David Livingstone Alves Melo, Giulianno Molina Silva, Rubens Adão Fainstein, Claudio dos Reis, Gerson Felisbino Corbo, Rossana Ramos, Helton Estrela Camacho, Cléber Pinto Vaisman, Fernanda Vaisman, Mário eBioMedicine Articles BACKGROUND: The diagnosis of cancer in Bethesda III/IV thyroid nodules is challenging as fine-needle aspiration (FNA) has limitations, and these cases usually require diagnostic surgery. As approximately 77% of these nodules are not malignant, a diagnostic test accurately identifying benign thyroid nodules can reduce “potentially unnecessary” surgery rates. We have previously reported the development and validation of a microRNA-based thyroid classifier (mir-THYpe) with high sensitivity and specificity, which could be performed directly from FNA smear slides. We sought to evaluate the performance of this test in real-world clinical routine to support clinical decisions and to reduce surgery rates. METHODS: We designed a real-world, prospective, multicentre study. Molecular tests were performed with FNA samples prepared at 128 cytopathology laboratories. Patients were followed-up from March 2018 until surgery or until March 2020 (patients with no indication for surgery). The final diagnosis of thyroid tissue samples was retrieved from postsurgical anatomopathological reports. FINDINGS: A total of 435 patients (440 nodules) classified as Bethesda III/IV were followed-up. The rate of avoided surgeries was 52·5% for all surgeries and 74·6% for “potentially unnecessary” surgeries. The test achieved 89·3% sensitivity, 81·65% specificity, 66·2% positive predictive value, and 95% negative predictive value. The test supported 92·3% of clinical decisions. INTERPRETATION: The reported data demonstrate that the use of the microRNA-based classifier in the real-world can reduce the rate of thyroid surgeries with robust performance and support clinical decision-making. FUNDING: The São Paulo Research-Foundation (FAPESP) and Onkos. Elsevier 2022-07-01 /pmc/articles/PMC9254359/ /pubmed/35785619 http://dx.doi.org/10.1016/j.ebiom.2022.104137 Text en © 2022 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Articles
Santos, Marcos Tadeu
Rodrigues, Bruna Moretto
Shizukuda, Satye
Oliveira, Andrei Félix
Oliveira, Miriane
Figueiredo, David Livingstone Alves
Melo, Giulianno Molina
Silva, Rubens Adão
Fainstein, Claudio
dos Reis, Gerson Felisbino
Corbo, Rossana
Ramos, Helton Estrela
Camacho, Cléber Pinto
Vaisman, Fernanda
Vaisman, Mário
Clinical decision support analysis of a microRNA-based thyroid molecular classifier: A real-world, prospective and multicentre validation study
title Clinical decision support analysis of a microRNA-based thyroid molecular classifier: A real-world, prospective and multicentre validation study
title_full Clinical decision support analysis of a microRNA-based thyroid molecular classifier: A real-world, prospective and multicentre validation study
title_fullStr Clinical decision support analysis of a microRNA-based thyroid molecular classifier: A real-world, prospective and multicentre validation study
title_full_unstemmed Clinical decision support analysis of a microRNA-based thyroid molecular classifier: A real-world, prospective and multicentre validation study
title_short Clinical decision support analysis of a microRNA-based thyroid molecular classifier: A real-world, prospective and multicentre validation study
title_sort clinical decision support analysis of a microrna-based thyroid molecular classifier: a real-world, prospective and multicentre validation study
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9254359/
https://www.ncbi.nlm.nih.gov/pubmed/35785619
http://dx.doi.org/10.1016/j.ebiom.2022.104137
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