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Development and Validation of an Endometriosis Diagnostic Method Based on Serum Biomarkers and Clinical Variables

Endometriosis affects more than 10% of women of reproductive age, significantly impacting their quality of life. Diagnosis typically takes 4 to 11 years from symptom onset. The gold standard for diagnosing this disease, laparoscopy, is invasive, contributing to this delay in diagnosis. Two studies w...

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Autores principales: Herranz-Blanco, Bárbara, Daoud, Elza, Viganò, Paola, García-Velasco, Juan Antonio, Colli, Enrico
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10377646/
https://www.ncbi.nlm.nih.gov/pubmed/37509088
http://dx.doi.org/10.3390/biom13071052
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author Herranz-Blanco, Bárbara
Daoud, Elza
Viganò, Paola
García-Velasco, Juan Antonio
Colli, Enrico
author_facet Herranz-Blanco, Bárbara
Daoud, Elza
Viganò, Paola
García-Velasco, Juan Antonio
Colli, Enrico
author_sort Herranz-Blanco, Bárbara
collection PubMed
description Endometriosis affects more than 10% of women of reproductive age, significantly impacting their quality of life. Diagnosis typically takes 4 to 11 years from symptom onset. The gold standard for diagnosing this disease, laparoscopy, is invasive, contributing to this delay in diagnosis. Two studies were conducted to develop a diagnostic test based on the combination of serum biomarkers and clinical variables. Study 1, the development study, aimed to: (i) confirm the ability of CA125, BDNF and clinical variables to differentiate between cases and controls, and (ii) develop a diagnostic algorithm based on these results. Study 2 validated the clinical performance of the developed in vitro diagnostic (IVD) test in diagnosing endometriosis. Serum samples and clinical variables extracted from psychometric questionnaires were obtained from the Oxford Endometriosis CaRe Centre biobank (UK). Case/control classification was performed based on laparoscopy and histological verification of the excised lesions. Studies 1 and 2 included n = 204 and n = 79 patients, respectively. Study 1 found a statistically significant difference between cases and controls for levels of both biomarkers. Of the assessed clinical variables from the patients’ medical histories, six were found to be significantly different between endometriosis cases and controls. CA125, BDNF and these six clinical variables were combined into a multivariable prediction model. In Study 2, the IVD test demonstrated sensitivity and specificity values of 46.2% (25.5–66.8%) and 100% (86.7–100%), respectively. Due to its high specificity, this IVD test is a simple and accurate rule-in test for early disease identification, even in the presence of non-specific symptoms.
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spelling pubmed-103776462023-07-29 Development and Validation of an Endometriosis Diagnostic Method Based on Serum Biomarkers and Clinical Variables Herranz-Blanco, Bárbara Daoud, Elza Viganò, Paola García-Velasco, Juan Antonio Colli, Enrico Biomolecules Article Endometriosis affects more than 10% of women of reproductive age, significantly impacting their quality of life. Diagnosis typically takes 4 to 11 years from symptom onset. The gold standard for diagnosing this disease, laparoscopy, is invasive, contributing to this delay in diagnosis. Two studies were conducted to develop a diagnostic test based on the combination of serum biomarkers and clinical variables. Study 1, the development study, aimed to: (i) confirm the ability of CA125, BDNF and clinical variables to differentiate between cases and controls, and (ii) develop a diagnostic algorithm based on these results. Study 2 validated the clinical performance of the developed in vitro diagnostic (IVD) test in diagnosing endometriosis. Serum samples and clinical variables extracted from psychometric questionnaires were obtained from the Oxford Endometriosis CaRe Centre biobank (UK). Case/control classification was performed based on laparoscopy and histological verification of the excised lesions. Studies 1 and 2 included n = 204 and n = 79 patients, respectively. Study 1 found a statistically significant difference between cases and controls for levels of both biomarkers. Of the assessed clinical variables from the patients’ medical histories, six were found to be significantly different between endometriosis cases and controls. CA125, BDNF and these six clinical variables were combined into a multivariable prediction model. In Study 2, the IVD test demonstrated sensitivity and specificity values of 46.2% (25.5–66.8%) and 100% (86.7–100%), respectively. Due to its high specificity, this IVD test is a simple and accurate rule-in test for early disease identification, even in the presence of non-specific symptoms. MDPI 2023-06-28 /pmc/articles/PMC10377646/ /pubmed/37509088 http://dx.doi.org/10.3390/biom13071052 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Herranz-Blanco, Bárbara
Daoud, Elza
Viganò, Paola
García-Velasco, Juan Antonio
Colli, Enrico
Development and Validation of an Endometriosis Diagnostic Method Based on Serum Biomarkers and Clinical Variables
title Development and Validation of an Endometriosis Diagnostic Method Based on Serum Biomarkers and Clinical Variables
title_full Development and Validation of an Endometriosis Diagnostic Method Based on Serum Biomarkers and Clinical Variables
title_fullStr Development and Validation of an Endometriosis Diagnostic Method Based on Serum Biomarkers and Clinical Variables
title_full_unstemmed Development and Validation of an Endometriosis Diagnostic Method Based on Serum Biomarkers and Clinical Variables
title_short Development and Validation of an Endometriosis Diagnostic Method Based on Serum Biomarkers and Clinical Variables
title_sort development and validation of an endometriosis diagnostic method based on serum biomarkers and clinical variables
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10377646/
https://www.ncbi.nlm.nih.gov/pubmed/37509088
http://dx.doi.org/10.3390/biom13071052
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