Abstract
Lung cancer (LC) is the leading cause of cancer‐related deaths worldwide. Early LC diagnosis is crucial to reduce the high case fatality rate of this disease. In this case–control study, we developed an accurate LC diagnosis test using retrospectively collected formalin‐fixed paraffin‐embedded (FFPE) human lung tissues and prospectively collected exhaled breath condensates (EBCs). Following international guidelines for diagnostic methods with clinical application, reproducible standard operating procedures (SOP) were established for every step comprising our LC diagnosis method. We analyzed the expression of distinct mRNAs expressed from GATA6 and NKX2‐1, key regulators of lung development. The Em/Ad expression ratios of GATA6 and NKX2‐1 detected in EBCs were combined using linear kernel support vector machines (SVM) into the LC score, which can be used for LC detection. LC score‐based diagnosis achieved a high performance in an independent validation cohort. We propose our method as a non‐invasive, accurate, and low‐price option to complement the success of computed tomography imaging (CT) and chest X‐ray (CXR) for LC diagnosis.
Highlights
Lung cancer patients are mostly asymptomatic at early stages
In the third phase, using the standard operating procedures (SOP) established in phases 1 and 2, an independent set of previously unseen exhaled breath condensates (EBCs) was collected from patients continuously enrolled in the clinic, in a blinded manner, thereby mimicking conditions of clinical use
Development and validation of the Lung cancer (LC) score as a simple clinical score for LC diagnosis Our results demonstrated that the Em/Ad expression ratios of GATA6 and NKX2-1 in the EBCs of LC patients can be used for LC detection
Summary
Lung cancer patients are mostly asymptomatic at early stages. In the majority of LC patients, traditional diagnostic strategies are initiated at advanced stages of the disease, when the overall condition of the patient is already impaired and prognosis is poor, as shown by the low 5-year patient survival of 1–5% (Herbst et al, 2008). Computed tomography imaging (CT) detects LC at an earlier stage than chest X-ray (CXR) (Henschke et al, 1999). 55–85% of the CT-detected LC can be surgically removed resulting in an improved 5-year patient survival of almost 52%
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