The presence of circulating genetically abnormal cells in blood predicts risk of lung cancer in individuals with indeterminate pulmonary nodules

Computed tomography is the standard method by which pulmonary nodules are detected. Greater than 40% of pulmonary biopsies are not lung cancer and therefore not necessary, suggesting that improved diagnostic tools are needed. The LungLB™ blood test was developed to aid the clinical assessment of ind...

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Bibliographic Details
Published in:	BMC pulmonary medicine Vol. 23; no. 1; p. 193
Main Authors:	Tahvilian, Shahram, Kuban, Joshua D, Yankelevitz, David F, Leventon, Daniel, Henschke, Claudia I, Zhu, Jeffrey, Baden, Lara, Yip, Rowena, Hirsch, Fred R, Reed, Rebecca, Brown, Ashley, Muldoon, Allison, Trejo, Michael, Katchman, Benjamin A, Donovan, Michael J, Pagano, Paul C
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 05-06-2023 BioMed Central BMC
Subjects:	Analysis Biopsy Biopsy, Needle Cancer Chronic obstructive pulmonary disease Computed tomography CT imaging Development and progression Diagnosis Early detection Genetic aspects Humans Hybridization Indeterminate nodules Laboratories Leukocytes Liquid biopsy Lung - pathology Lung cancer Lung Neoplasms - diagnosis Lung Neoplasms - genetics Lung Neoplasms - pathology Lung nodules Malignancy Medical diagnosis Medical screening Metastasis Mortality Motility Multiple Pulmonary Nodules - pathology Multivariate analysis Peripheral blood Prediction models Prospective Studies Pulmonary nodules Pulmonology Risk factors Solitary Pulmonary Nodule - pathology United States New York United States > US Liquid biopsy Lung cancer Pulmonary nodules Early detection Indeterminate nodules
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Summary:	Computed tomography is the standard method by which pulmonary nodules are detected. Greater than 40% of pulmonary biopsies are not lung cancer and therefore not necessary, suggesting that improved diagnostic tools are needed. The LungLB™ blood test was developed to aid the clinical assessment of indeterminate nodules suspicious for lung cancer. LungLB™ identifies circulating genetically abnormal cells (CGACs) that are present early in lung cancer pathogenesis. LungLB™ is a 4-color fluorescence in-situ hybridization assay for detecting CGACs from peripheral blood. A prospective correlational study was performed on 151 participants scheduled for a pulmonary nodule biopsy. Mann-Whitney, Fisher's Exact and Chi-Square tests were used to assess participant demographics and correlation of LungLB™ with biopsy results, and sensitivity and specificity were also evaluated. Participants from Mount Sinai Hospital (n = 83) and MD Anderson (n = 68), scheduled for a pulmonary biopsy were enrolled to have a LungLB™ test. Additional clinical variables including smoking history, previous cancer, lesion size, and nodule appearance were also collected. LungLB™ achieved 77% sensitivity and 72% specificity with an AUC of 0.78 for predicting lung cancer in the associated needle biopsy. Multivariate analysis found that clinical and radiological factors commonly used in malignancy prediction models did not impact the test performance. High test performance was observed across all participant characteristics, including clinical categories where other tests perform poorly (Mayo Clinic Model, AUC = 0.52). Early clinical performance of the LungLB™ test supports a role in the discrimination of benign from malignant pulmonary nodules. Extended studies are underway.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1471-2466 1471-2466
DOI:	10.1186/s12890-023-02433-4