ArticleBiomedical research and clinical practice2018
Risk assessment for indeterminate pulmonary nodules using a novel, plasma-protein based biomarker assay.
Article in Biomedical research and clinical practice, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 19 citations in OpenAlex.
- A multivariate cell-based liquid biopsy for lung nodule risk stratification: Analytical validation and early clinical evaluation.The journal of liquid biopsy · 2025Article
- Historic p87 Is Diagnostic for Lung Cancer Preceding Clinical Presentation by at Least 4 Years.Cancers · 2025Article
- Lung cancer screening: where do we stand?Breathe (Sheffield, England) · 2024Review
- Circulating proteome for pulmonary nodule malignancy.Journal of the National Cancer Institute · 2023Article
- Biomarkers in Lung Cancer Screening: a Narrative Review.Current challenges in thoracic surgery · 2023Article
- Clinical Scores, Biomarkers and IT Tools in Lung Cancer Screening-Can an Integrated Approach Overcome Current Challenges?Cancers · 2023Review
- Article
- The impact of the lung EDRN-CVC on Phase 1, 2, & 3 biomarker validation studies.Cancer biomarkers : section A of Disease markers · 2022Article
- Integrated Biomarkers for the Management of Indeterminate Pulmonary Nodules.American journal of respiratory and critical care medicine · 2021Article
- Noninvasive biomarkers for lung cancer diagnosis, where do we stand?Journal of thoracic disease · 2020Review
- Analytical validation of a novel multi-analyte plasma test for lung nodule characterization.Biomedical research and reviews · 2018Article
Corrections and comments
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Authors and funding
17 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundThe increase in lung cancer screening is intensifying the need for a noninvasive test to characterize the many indeterminate pulmonary nodules (IPN) discovered. Correctly identifying non-cancerous nodules is needed to reduce overdiagnosis and overtreatment. Alternatively, early identification of malignant nodules may represent a potentially curable form of lung cancer.
objectiveTo develop and validate a plasma-based multiplexed protein assay for classifying IPN by discriminating between those with a lung cancer diagnosis established pathologically and those found to be clinically and radiographically stable for at least one year.
methodsUsing a novel technology, we developed assays for plasma proteins associated with lung cancer into a panel for characterizing the risk that an IPN found on chest imaging is malignant. The assay panel was evaluated with a cohort of 277 samples, all from current smokers with an IPN 4-30 mm. Subjects were divided into training and test sets to identify a Support Vector Machine (SVM) model for risk classification containing those proteins and clinical factors that added discriminatory information to the Veteran's Affairs (VA) Clinical Factors Model. The algorithm was then evaluated in an independent validation cohort.
resultsAmong the 97 validation study subjects, 68 were grouped as having intermediate risk by the VA model of which the SVM model correctly identified 44 (65%) of these intermediate-risk samples as low (n=16) or high risk (n=28). The SVM model negative predictive value (NPV) was 94% and its sensitivity was 94%.
conclusionThe performance of the novel plasma protein biomarker assay supports its use as a noninvasive risk assessment aid for characterizing IPN. The high NPV of the SVM model suggests its application as a rule-out test to increase the confidence of providers to avoid aggressive interventions for their patients for whom the VA model result is an inconclusive, intermediate risk.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.