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Validation of a multiprotein plasma classifier to identify benign lung nodules
Anil Vachani1, Harvey I Pass, William N Rom
1*Division of Pulmonary, Allergy, and Critical Care Medicine, Penn Lung Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; †Department of Cardiothoracic Surgery, New York University Langone Medical Center, New York, New York; ‡Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine and §Department of Environmental Medicine, New York University School of Medicine, New York University Langone Medical Center, New York, New York; ‖Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota; ¶Unité de Recherche en Pneumologie, Centre de Recherche de l'Hôpital Laval, Institut Universitaire de Cardiologie et de Pneumologie de l'Université Laval; Québec, Canada; ≠Integrated Diagnostics, Seattle, Washington; **Respiratory Institute, Cleveland Clinic, Cleveland, Ohio; ††Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; ‡‡Division of Pulmonary and Critical Care Medicine, University of Washington, Seattle, Washington; §§Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, Veterans Administration Eastern Colorado Healthcare System, University of Colorado Denver School of Medicine, Denver, Colorado; ‖‖Statistics Consultant, Carlsbad, California; ¶¶Thoracic Program, Vanderbilt-Ingram Comprehensive Cancer Center, Nashville, Tennessee; ≠≠Department of Veterans Affairs, Tennessee Valley Healthcare System, Nashville Campus, Nashville, Tennessee.
A new proteomic classifier accurately identifies likely benign indeterminate pulmonary nodules (IPNs) using plasma protein levels. This noninvasive tool aids clinical decisions, potentially reducing unnecessary invasive procedures for lung nodules.
Area of Science:
- Proteomics
- Biomarker Discovery
- Pulmonary Medicine
Background:
- Indeterminate pulmonary nodules (IPNs) often lead to unnecessary invasive procedures due to unclear etiology.
- Molecular biomarkers in plasma show promise for improved diagnostic accuracy.
- A validated classifier could reduce healthcare costs and patient risk.
Purpose of the Study:
- To validate a multivariate proteomic classifier for identifying likely benign indeterminate pulmonary nodules (IPNs).
- To assess the classifier's negative predictive value (NPV) in patients with 8 to 30 mm IPNs.
- To evaluate the classifier's performance as a diagnostic adjunct.
Main Methods:
- Retrospective, multicenter, case-control study.
- Multiple reaction monitoring mass spectrometry assay for plasma protein expression.
- Validation using an independent set of 141 lung nodule-associated plasma samples.
Main Results:
- The classifier achieved 92% sensitivity and 20% specificity, with a 90% NPV for likely benign nodules.
- Performance metrics were independent of patient demographics and clinical factors.
- The classifier showed incremental diagnostic value when combined with a clinical model.
Conclusions:
- A proteomic classifier offers a noninvasive method to estimate the likelihood of benign etiology for IPNs.
- This tool can serve as a valuable adjunct in the clinical assessment of patients with lung nodules.
- Potential to reduce unnecessary invasive procedures and improve diagnostic pathways.
