title: miR-Test: a blood test for lung cancer early detection.
abstract: Lung cancer is the leading cause of cancer death worldwide. Low-dose computed tomography screening (LDCT) was recently shown to anticipate the time of diagnosis, thus reducing lung cancer mortality. However, concerns persist about the feasibility and costs of large-scale LDCT programs. Such concerns may be addressed by clearly defining the target "high-risk" population that needs to be screened by LDCT. We recently identified a serum microRNA signature (the miR-Test) that could identify the optimal target population. Here, we performed a large-scale validation study of the miR-Test in high-risk individuals (n = 1115) enrolled in the Continuous Observation of Smoking Subjects (COSMOS) lung cancer screening program. The overall accuracy, sensitivity, and specificity of the miR-Test are 74.9% (95% confidence interval [CI] = 72.2% to 77.6%), 77.8% (95% CI = 64.2% to 91.4%), and 74.8% (95% CI = 72.1% to 77.5%), respectively; the area under the curve is 0.85 (95% CI = 0.78 to 0.92). These results argue that the miR-Test might represent a useful tool for lung cancer screening in high-risk individuals.
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Francesca
authors: F
authors: Montani
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Matteo Jacopo
authors: MJ
authors: Marzi
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Fabio
authors: F
authors: Dezi
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Elisa
authors: E
authors: Dama
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Rose Mary
authors: RM
authors: Carletti
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Giuseppina
authors: G
authors: Bonizzi
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Raffaella
authors: R
authors: Bertolotti
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Massimo
authors: M
authors: Bellomi
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Cristiano
authors: C
authors: Rampinelli
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Patrick
authors: P
authors: Maisonneuve
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Lorenzo
authors: L
authors: Spaggiari
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Giulia
authors: G
authors: Veronesi
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Francesco
authors: F
authors: Nicassio
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Pier Paolo
authors: PP
authors: Di Fiore
authors: Molecular Medicine Program, Department of Experimental Oncology, European Institute of Oncology, Milan, Italy (FM, FD, ED, RMC, GB, PPDF, FB); Center for Genomic Science of IIT@SEMM, Istituto Italiano di Tecnologia, 20139 Milan, Italy (MJM, FN); Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy (ED, PM); IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy (RMC, PPDF); Division of Thoracic Surgery, European Institute of Oncology, Milan, Italy (RB, LS, GV); Division of Radiology, European Institute of Oncology, Milan, Italy (MB, CR); Department of Scienze della Salute, University of Milan, Milan, Italy (MB, LS, PPDF).
authors: Fabrizio
authors: F
authors: Bianchi
mesh_terms: D000328:Adult; D000368:Aged; D019540:Area Under Curve; D014408:Biomarkers, Tumor / Q000097:blood*; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000097:blood* / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000209:etiology / Q000235:genetics; D008297:Male; D035683:MicroRNAs / Q000097:blood*; D008875:Middle Aged; D011159:Population Surveillance; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D012907:Smoking / Q000009:adverse effects; D014057:Tomography, X-Ray Computed
chemical_list: D014408:Biomarkers, Tumor; D035683:MicroRNAs