Effect of a Rule-in Biomarker Test on Pulmonary Nodule Management: A Survey of Pulmonologists and Thoracic Surgeons

Tanner, Nichole T.; Brasher, Paul Bradley; Jett, James R.; Silvestri, Gerard A.

doi:10.1016/j.cllc.2019.05.004

Cited by 9 publications

(2 citation statements)

References 13 publications

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“…Consistent with our previous reports [17][18][19][20], they showed different lengths in nucleotides (Table 2). Distinct from other integrated prediction models for pulmonary nodules [33][34][35][36][37], our prediction rules did not integrate other clinical risk factors, including age [38], smoking history [39][40][41], irregular nodule edges [42], emphysema [43,44], fluorodeoxyglucose-PET avidity [45,46], etc. We used FDA-cleared equipment and reagents available for in vitro diagnostic use or for R&D, and methods for evaluating pfeRNAs meeting the requirements for the CLIA-compliant LDT.…”

Section: Discussionmentioning

confidence: 96%

A Cost-Effective and Non-Invasive pfeRNA-Based Test Differentiates Benign and Suspicious Pulmonary Nodules from Malignant Ones

Liu

Wang

Huang

et al. 2021

ncRNA

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The ability to differentiate between benign, suspicious, and malignant pulmonary nodules is imperative for definitive intervention in patients with early stage lung cancers. Here, we report that plasma protein functional effector sncRNAs (pfeRNAs) serve as non-invasive biomarkers for determining both the existence and the nature of pulmonary nodules in a three-stage study that included the healthy group, patients with benign pulmonary nodules, patients with suspicious nodules, and patients with malignant nodules. Following the standards required for a clinical laboratory improvement amendments (CLIA)-compliant laboratory-developed test (LDT), we identified a pfeRNA classifier containing 8 pfeRNAs in 108 biospecimens from 60 patients by sncRNA deep sequencing, deduced prediction rules using a separate training cohort of 198 plasma specimens, and then applied the prediction rules to another 230 plasma specimens in an independent validation cohort. The pfeRNA classifier could (1) differentiate patients with or without pulmonary nodules with an average sensitivity and specificity of 96.2% and 97.35% and (2) differentiate malignant versus benign pulmonary nodules with an average sensitivity and specificity of 77.1% and 74.25%. Our biomarkers are cost-effective, non-invasive, sensitive, and specific, and the qPCR-based method provides the possibility for automatic testing of robotic applications.

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Section: Discussionmentioning

confidence: 96%

A Cost-Effective and Non-Invasive pfeRNA-Based Test Differentiates Benign and Suspicious Pulmonary Nodules from Malignant Ones

Liu

Wang

Huang

et al. 2021

ncRNA

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“…Pulmonary nodule management guidelines specify that expert clinician intuition, rather than risk prediction models, is an acceptable alternative to assessing nodule pretest probability of malignancy (5,9). In one survey of over 400 practicing pulmonologists and thoracic surgeons, only 28% reported routinely using nodule prediction calculators, while the majority relied on their intuition (23).…”

Section: Clinician-assessed Nodule Risk Evaluationmentioning

confidence: 99%

Approaches to lung nodule risk assessment: clinician intuition versus prediction models

Tanner

2020

J Thorac Dis

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Pulmonary nodules are increasingly identified on imaging exams performed for a number of clinical presentations and can pose a diagnostic problem for clinicians. Guideline-directed management algorithms are structured on nodule pre-test probability of malignancy. The risk of malignancy can be clinician-assigned or calculated utilizing validated risk prediction calculators. Once pre-test probability of cancer is estimated, nodule management options range from a conservative approach with serial imaging to more invasive measures including biopsy procedures or surgical resection. Here we review pulmonary nodule management with a focus on methods for assigning malignancy risk and highlight novel ways currently under active research to improve nodule risk assessment and management.

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The American Cancer Society National Lung Cancer Roundtable strategic plan: Optimizing strategies for lung nodule evaluation and management

Barta,

Farjah,

Thomson

et al. 2024

Cancer

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Lung nodules are frequently detected on low‐dose computed tomography scans performed for lung cancer screening and incidentally detected on imaging performed for other reasons. There is wide variability in how lung nodules are managed by general practitioners and subspecialists, with high rates of guideline‐discordant care. This may be due in part to the level of evidence underlying current practice guideline recommendations (primarily based on findings from uncontrolled studies of diagnostic accuracy). The primary aims of lung nodule management are to minimize harms of diagnostic evaluations while expediting the evaluation, diagnosis, and treatment of lung cancer. Potentially useful tools such as lung cancer probability calculators, automated methods to identify patients with nodules in the electronic health record, and multidisciplinary team evaluation are often underused due to limited availability, accessibility, and/or provider knowledge. Finally, relatively little attention has been paid to identifying and reducing disparities among individuals with screening‐detected or incidentally detected lung nodules. This contribution to the American Cancer Society National Lung Cancer Roundtable Strategic Plan aims to identify and describe these knowledge gaps in lung nodule management and propose recommendations to advance clinical practice and research. Major themes that are addressed include improving the quality of evidence supporting lung nodule evaluation guidelines, strategically leveraging information technology, and placing emphasis on equitable approaches to nodule management. The recommendations outlined in this strategic plan, when carried out through interdisciplinary efforts with a focus on health equity, ultimately aim to improve early detection and reduce the morbidity and mortality of lung cancer.Plain Language Summary Lung nodules may be identified on chest scans of individuals who undergo lung cancer screening (screening‐detected nodules) or among patients for whom a scan was performed for another reason (incidental nodules). Although the vast majority of lung nodules are not lung cancer, it is important to have evidence‐based, standardized approaches to the evaluation and management of a lung nodule. The primary aims of lung nodule management are to diagnose lung cancer while it is still in an early stage and to avoid unnecessary procedures and other harms.

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Effect of a Rule-in Biomarker Test on Pulmonary Nodule Management: A Survey of Pulmonologists and Thoracic Surgeons

Cited by 9 publications

References 13 publications

A Cost-Effective and Non-Invasive pfeRNA-Based Test Differentiates Benign and Suspicious Pulmonary Nodules from Malignant Ones

A Cost-Effective and Non-Invasive pfeRNA-Based Test Differentiates Benign and Suspicious Pulmonary Nodules from Malignant Ones

Approaches to lung nodule risk assessment: clinician intuition versus prediction models

The American Cancer Society National Lung Cancer Roundtable strategic plan: Optimizing strategies for lung nodule evaluation and management

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