Clinical validation of a blood-based classifier for diagnostic evaluation of asymptomatic individuals with pulmonary nodules

Autor: Charles E. Birse, Jennifer L. Tomic, Harvey I. Pass, William N. Rom, Robert J. Lagier
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Zdroj: Clinical Proteomics, Vol 14, Iss 1, Pp 1-9 (2017)
Druh dokumentu: article
ISSN: 1542-6416
1559-0275
DOI: 10.1186/s12014-017-9158-9
Popis: Abstract Background The number of pulmonary nodules detected in the US is expected to increase substantially following recent recommendations for nationwide CT-based lung cancer screening. Given the low specificity of CT screening, non-invasive adjuvant methods are needed to differentiate cancerous lesions from benign nodules to help avoid unnecessary invasive procedures in the asymptomatic population. We have constructed a serum-based multi-biomarker panel and assessed its clinical accuracy in a retrospective analysis of samples collected from participants with suspicious radiographic findings in the Prostate, Lung, Chest and Ovarian (PLCO) cancer screening trial. Methods Starting with a set of 9 candidate biomarkers, we identified 8 that exhibited limited pre-analytical variability with increasing clotting time, a key pre-analytical variable associated with the collection of serum. These 8 biomarkers were evaluated in a training study consisting of 95 stage I NSCLC patients and 186 smoker controls where a 5-biomarker pulmonary nodule classifier (PNC) was selected. The clinical accuracy of the PNC was determined in a blinded study of asymptomatic individuals comprising 119 confirmed malignant nodule cases and 119 benign nodule controls selected from the PLCO screening trial. Results A PNC comprising 5 biomarkers: CEA, CYFRA 21-1, OPN, SCC, and TFPI, was selected in the training study. In an independent validation study, the PNC resolved lung cancer cases from benign nodule controls with an AUC of 0.653 (p
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