Abstract

Simple SummaryLung cancer is the most common cause of cancer-related deaths globally. Patients diagnosed at early-stage (0–I) have a higher survival rate than the metastasized stages (III–IV). Thus, there is great potential to reduce mortality by diagnosing lung cancer at stage 0~I through community screening. LDCT is a promising method, but it has a high false-positive rate. Therefore, a biomarker test that can be used in combination with LDCT for lung cancer screening to reduce false-positive rates is highly awaited. The present study evaluated the applicability of 9G testTM Cancer/Lung test to detect stage 0~IV lung cancer. 9G testTM Cancer/Lung test detects stage I, stage II, stage III, and stage IV cancers with the sensitivities of 77.5%, 78.1%, 67.4%, and 33.3%, respectively, at the specificity of 97.3%. These results indicate that the 9G testTM Cancer/Lung can be used in conjunction with LDCT to screen lung cancer.A complimentary biomarker test that can be used in combination with LDCT for lung cancer screening is highly desirable to improve the diagnostic capacity of LDCT and reduce the false-positive rates. Most importantly, the stage I lung cancer detection rate can be dramatically increased by the simultaneous use of a biomarker test with LDCT. The present study was conducted to evaluate 9G testTM Cancer/Lung’s sensitivity and specificity in detecting Stage 0~IV lung cancer. The obtained results indicate that the 9G testTM Cancer/Lung can detect lung cancer with overall sensitivity and specificity of 75.0% (69.1~80.3) and 97.3% (95.0~98.8), respectively. The detection of stage I, stage II, stage III, and stage IV cancers with sensitivities of 77.5%, 78.1%, 67.4%, and 33.3%, respectively, at the specificity of 97.3% have never been reported before. The receiver operating characteristic curve analysis allowed us to determine the population-weighted AUC of 0.93 (95% CI, 0.91–0.95). These results indicate that the 9G testTM Cancer/Lung can be used in conjunction with LDCT to screen lung cancer. Furthermore, obtained results indicate that the use of 9G testTM Cancer/Lung with LDCT for lung cancer screening can increase stage I cancer detection, which is crucial to improve the currently low 5-year survival rates.

Highlights

  • Lung cancer is the most common cause of cancer-related deaths globally, accounting for about18.4% of total cancer deaths [1]

  • We have developed a 9G testTM Cancer/Lung, a test that allows the diagnosis of stage 0~IV lung cancers. 9G testTM Cancer/Lung, which has high applicability in the health care programs for lung cancer screening as a supplementary to the Low-dose computed tomography (LDCT), detects four biomarkers in the plasma samples

  • These results indicate that the 9G testTM Cancer/Lung has a high potential for a community screening of lung cancer in conjunction with LDCT

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Summary

Introduction

Lung cancer is the most common cause of cancer-related deaths globally, accounting for about. 18.4% of total cancer deaths [1]. In 2018 alone, around 2 million individuals were identified with lung cancer, and nearly 1.7 million deaths were reported due to lung cancer on a global scale [2]. Most lung cancer cases are diagnosed at advanced stages because of the asymptomatic nature of lung neoplasms. In cases of advanced lung cancer, cure with current therapies is unlikely. The 5-year survival rate in lung cancer is meager. Patients diagnosed at an early stage have a higher survival rate than the latter, localized, and metastasized stages

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