Development and Multi-center Validation of a Breathomics-Based Triage Tool for Lung Cancer: A Prospective Study of 5,214 Participants.
Exhaled-breath triage test detected lung cancer with 93.1% sensitivity in external validation.
Development and Multi-center Validation of a Breathomics-Based Triage Tool for Lung Cancer: A Prospective Study of 5,214 Participants.
The inherent false-positive rate of computed tomography (computed tomography) necessitates efficient, non-invasive triage tools to distinguish lung cancer (lung cancer) from benign mimics, thereby streamlining early detection and mitigating unnecessary invasive procedures.
Were allocated into a discovery cohort (n = 4,669) and a geographically independent external validation cohort (n = 545).
found over 9 in 10 lung cancers, missing few real cases
The integrated model achieved an area under the receiver operating characteristic curve (AUC) of 0.891 (95% confidence interval (CI): 0.864-0.915) in the independent internal testing set.
In the independent external validation, the model maintained robust performance (AUC 0.850, 95% CI: 0.805-0.890).
Importantly, in the intended-use pulmonary medicine subgroup (n=155), the sensitivity was 91.4%, with specificity and negative predictive value reaching 55.8% and 89.0%, respectively.
Subgroup analyses confirmed consistent efficacy across diverse clinical scenarios, notably maintaining robust accuracy in detecting early-stage disease (AUC 0.849).
This study represents the largest prospective validation of a mass-spectrometry-based breath test to date. The validated prediction model holds potential to serve as a robust, non-invasive triage tool.
Its integration into the diagnostic pathway shows promise for enhancing efficiency and reducing unnecessary biopsies, particularly in respiratory outpatient settings.