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Risk assessment for indeterminate pulmonary nodules using a novel, plasma-protein based biomarker assay.
Neil N Trivedi1, Mehrdad Arjomandi1, James K Brown1
1San Francisco Veterans Affairs Medical Center, 4150 Clement St, San Francisco, CA, USA.
Biomedical Research and Clinical Practice
|September 11, 2020
Summary
A new plasma protein test can help doctors assess indeterminate pulmonary nodules (IPN) in lung cancer screening. This noninvasive assay accurately identifies high-risk nodules, reducing unnecessary treatments.
Area of Science:
- Pulmonary Medicine
- Oncology
- Biomarker Discovery
Background:
- Increasing lung cancer screening necessitates noninvasive tests for indeterminate pulmonary nodules (IPN).
- Accurate characterization of IPN is crucial to prevent overdiagnosis and overtreatment of benign cases.
- Early detection of malignant nodules can improve treatment outcomes for potentially curable lung cancer.
Purpose of the Study:
- To develop and validate a plasma-based multiplexed protein assay for classifying IPN.
- To differentiate between IPN with confirmed lung cancer and those stable for over a year.
- To create a noninvasive tool aiding in the risk stratification of pulmonary nodules.
Main Methods:
- Developed plasma protein assays into a panel for lung cancer risk characterization.
- Utilized a Support Vector Machine (SVM) model incorporating proteins and clinical factors.
- Evaluated the assay panel in training and independent validation cohorts of current smokers with IPN.
Main Results:
- The SVM model correctly classified 65% of intermediate-risk IPN identified by the VA model.
- Achieved a negative predictive value (NPV) of 94% and a sensitivity of 94% in the validation cohort.
- Demonstrated the assay's ability to refine risk assessment for indeterminate pulmonary nodules.
Conclusions:
- The plasma protein biomarker assay shows promise as a noninvasive aid for characterizing IPN.
- The high NPV of the SVM model supports its use as a rule-out test for benign nodules.
- This assay can increase provider confidence in managing patients with inconclusive intermediate-risk IPN, potentially avoiding aggressive interventions.
