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

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机构: [1]Guangdong Key Laboratory of Liver Disease Research, The Third Affiliated Hospital, Sun Yat-Sen University, 600 Tianhe Road, Tianhe District, Guangzhou 510630, China. [2]The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, 1650 Orleans Street, Baltimore, MD 21287, USA. [3]Department of Thoracic Medical Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Beijing Institute for Cancer Research, 52 Fucheng Road, Haidian District, Beijing 100142, China. [4]State Key Laboratory of Respiratory Disease, Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences, Huangpu District, Guangzhou 510530, China. [5]China-New Zealand Joint Laboratory on Biomedicine and Health, Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences, Huangpu District, Guangzhou 510530, China. [6]Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Beijing Institute for Cancer Research, 52 Fucheng Road, Haidian District, Beijing 100142, China. [7]Thoracic Surgery Department of Peking Union Medical College Hospital, Dongcheng District, Beijing 100034, China. [8]Department of Thoracic Surgery, Lung Cancer Center, Xuanwu Hospital, Capital Medical University, 45 Changchun Street, Xicheng District, Beijing 100053, China. [9]Thoracic Surgery Department of Peking University, The First Hospital, Xicheng District, Beijing 100034, China. [10]Institute for Basic Biomedical Sciences, Johns Hopkins School of Medicine, 733 North Broadway, Baltimore, MD 21205, USA. [11]Department of Oncology, Sol Goldman Pancreatic Cancer Research Center, Johns Hopkins Medical Institutions, Baltimore, MD 21287, USA. [12]The Pathology Molecular Diagnostics Laboratory, Johns Hopkins School of Medicine, 600 N Wolfe St., Baltimore, MD 21287, USA. [13]Department of Thoracic Surgery, Sichuan Cancer Center Hospital & Institute, School of Medicine, University of Electronic Science and Technology of China, Chengdu 611731, China.
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关键词: pfeRNA non-invasive biomarker pulmonary nodules NSCLC CLIA LDT

摘要:
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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最新[2023]版:
Q2 BIOCHEMISTRY & MOLECULAR BIOLOGY Q2 GENETICS & HEREDITY

影响因子: 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

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第一作者机构: [1]Guangdong Key Laboratory of Liver Disease Research, The Third Affiliated Hospital, Sun Yat-Sen University, 600 Tianhe Road, Tianhe District, Guangzhou 510630, China.
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