CLINICAL APPLICATION OF EXPERT SOFTWARE BASED ON SIX TUMOUR BIOMARKERS TO STRATIFY THE RISK OF LUNG CANCER IN A PULMONARY RAPID DIAGNOSIS UNIT

Molina, Rafael; Trapé, Jaume; Garrido, Adolfo; Salas, Ernesto; de Ceballos, Rosa Mª. Domínguez Gutierrez; Gundín, Simón; Justel, Antonio León; de Burgos, Marta García; Rivas, Juana Piedad; Ángel Julián Ansón, M.; Garrido, Manuel Matos; García, Sofía Lorenzo; Marrades, Ramón; Atorrasagasti, Nekane Múgica; Crespo, Estefanía Luque; López-Ramírez, Cecilia; Herrero, Fernando Gustavo Gutiérrez; González-Fernández, Carolina; Robles, Victoria Villalta; Cruz González Cocaño, Mª; Álvarez, Mónica Ramos; Carvalho Marta, José; García, Clara Jiménez; Vicente, Raquel Cabezón; Pavón Masa, Mª.; de la Maleta Úbeda, Ruth Sáez; Bernadich, Oscar; Trigueros, Graciliano Estrada; Orejas, Aurora; Carlos Santana Astudillo, J.; Trapé-Úbeda, J.; Barco-Sánchez, Antonio

doi:10.1016/j.arbres.2025.12.007

Archivos de Bronconeumología

ISSN: 0300-2896

Archivos de Bronconeumologia is an international journal that publishes original studies whose content is based upon results of research initiatives dealing with several aspects of respiratory medicine including epidemiology, respiratory physiology, pathophysiology of respiratory diseases, clinical management, thoracic surgery, pediatric lung diseases, respiratory critical care, respiratory allergy and translational research. Other types of articles such as editorials, reviews, and different types of letters are also published in the journal. Additionally, the journal expresses the voice of the following scientific societies: the Spanish Respiratory Society of Pneumology and Thoracic Surgery (SEPAR; https://www.separ.es/), the Latin American Thoracic Society (ALAT; https://alatorax.org/), and the Iberian American Association of Thoracic Surgery (AIACT; http://www.aiatorax.com/).

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Rafael Molina1, Jaume Trapé7, Adolfo Garrido2, Ernesto Salas4, Rosa Mª. Domínguez Gutierrez de Ceballos5, Simón Gundín6, Antonio León Justel3, Marta García de Burgos8, Juana Piedad Rivas9, M. Ángel Julián Ansón10, Manuel Matos Garrido11, Sofía Lorenzo García12, Ramón Marrades13, Nekane Múgica Atorrasagasti14, Estefanía Luque Crespo15, Cecilia López-Ramírez16, Fernando Gustavo Gutiérrez Herrero17, Carolina González-Fernández7, Victoria Villalta Robles8, Mª Cruz González Cocaño19..., Mónica Ramos Álvarez10, José Carvalho Marta11, Clara Jiménez García12, Raquel Cabezón Vicente2, Mª. Pavón Masa15, Ruth Sáez de la Maleta Úbeda6, Oscar Bernadich18, Graciliano Estrada Trigueros20, Aurora Orejas19, J. Carlos Santana Astudillo14, J. Trapé-Úbeda21, Antonio Barco-Sánchez3,*Ver más

1 Clinical Biochemistry Department (Oncobiology Unit), Centro de Diagnóstico Biomédico (CDB), Hospital Clinic, IDIBAPS, University of Barcelona, Spain

2 Clinical Biochemistry Department, Hospital Donostia, San Sebastian, Spain

3 Clinical Biochemistry Department, University Hospital Virgen Macarena, Seville, Spain

4 Clinical Analysis Department, Hospital San Juan de Dios, Seville, Spain

5 Clinical Analysis Department, University Hospital Virgen del Rocío, Seville, Spain

6 Clinical Analysis Department, Burgos University Hospital, Burgos, Spain

7 Laboratory Medicine, Althaia Xarxa Assistencial Universitària de Manresa, Spain

8 Clinical Analysis Department, General Hospital of Segovia, Segovia, Spain

9 Pneumology Department, Leon University Healthcare Complex, Leon, Spain

10 Clinical Biochemistry Department, Clinical University Hospital Lozano Blesa, Zaragoza, Spain

11 Clinical Pathology Department, Centro Hospitalar Universitario Lisboa Central, Lisbon, Portugal

12 Clinical Analysis Department, University General Hospital of Alicante, Alicante, Spain

13 Respiratory Institute, Hospital Clinic, IDIBAPS, University of Barcelona, Spain

14 Pneumology Department, Hospital Donostia, San Sebastian, Spain

15 Pneumology Department, University Hospital Virgen Macarena, Seville, Spain

16 Pneumology Department, University Hospital Virgen del Rocío, Seville, Spain

17 Pneumology Department, Burgos University Hospital, Burgos, Spain

18 Pneumology Department, Althaia Xarxa Assistencial Universitària de Manresa, Spain

19 Clinical Analysis Department, Leon University Healthcare Complex, Leon, Spain

20 Pneumology Department, General Hospital of Segovia, Segovia, Spain

21 General Directorate of Health Planning and Research, Ministry of Health, Generalitat de Catalunya, Spain

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ABSTRACT

Objectives: Diagnostic tools that stratify lung cancer (LC) risk can help prioritize care for patients at the highest risk and optimize time and procedures to achieve the final diagnosis. We have previously demonstrated that six tumour biomarkers (TBs) - CEA, CYFRA 21.1, CA 15-3, SCC Ag, ProGRP, and NSE - can help assess LC risk. We developed expert software that combines these TBs with clinical and imaging data to estimate LC risk.

Methods: The diagnostic accuracy of this expert software was evaluated in a multicentre study.We prospectively recruited 2,005 individuals referred to 12 reference hospitals in Spain and Portugal for suspicion of LC. The six TBs were determined and the expert software was applied to all patients and correlated with the final diagnosis.

Results: A final diagnosis of LC was made in 1,392 patients. The expert software yielded 87.7% sensitivity, 75.5% specificity, 89.0% positive predictive value and 73.0% negative predictive value. Sensitivity increased with tumour size and extension. The software also provides histological information, correctly predicting cancer in 98.4% of small-cell LC and 93.2% of non-small-cell LC, which correlates with the histological diagnosis of 90% and 91.2%, respectively.

Conclusions: The expert software developed provides excellent diagnostic accuracy for diagnosing LC. Accordingly, this software can help stratify the risk of LC and prioritize the evaluation of patients at higher risk, optimizing procedures based on risk and knowledge of the most likely histological type, and providing a valuable tool for risk stratification and clinical decision support, particularly in Rapid Diagnostic Units.

Keywords:

Lung cancer

Diagnosis

Tumour biomarkers

Expert software

Risk stratification

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