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Assessing the 9G Technology Blood Test for Predicting Lung Cancer in Patients with CT-Detected Lung Nodules: A Multicenter Clinical Trial.

Authors :
Kim, So Yeon
Park, Young Sik
Kim, In Ae
Kim, Hee Joung
Lee, Kye Young
Source :
Cancers. Nov2024, Vol. 16 Issue 22, p3737. 10p.
Publication Year :
2024

Abstract

Simple Summary: Lung nodules detected by computed tomography (CT) often require invasive procedures for definitive diagnosis. With the increasing use of CT, incidental lung nodules have increased significantly. An adjunctive blood-based biomarker test that predicts lung cancer risk could reduce unnecessary interventions and focus diagnostic efforts on high-risk patients. This study introduces a blood-based biomarker test that predicts lung cancer risk in CT-detected nodules with a sensitivity of 78.4% (95% CI: 75.7–81.1) and a specificity of 93.1% (95% CI: 90.0–96.3). Background and Objectives: Lung nodules detected by chest computed tomography (CT) often require invasive biopsies for definitive diagnosis, leading to unnecessary procedures for benign lesions. A blood-based biomarker test that predicts lung cancer risk in CT-detected nodules could help stratify patients and direct invasive diagnostics toward high-risk individuals. Methods: In this multicenter, single-blinded clinical trial, we evaluated a test measuring plasma levels of p53, anti-p53 autoantibodies, CYFRA 21-1, and anti-CYFRA 21-1 autoantibodies in patients with CT-detected lung nodules. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated, and subgroup analyses by gender, age, and smoking status were performed. A total of 1132 patients who had CT-detected lung nodules, including 885 lung cancer cases and 247 benign lesions, were enrolled from two academic hospitals in South Korea. Results: The test demonstrated a sensitivity of 78.4% (95% CI: 75.7–81.1) and specificity of 93.1% (95% CI: 90.0–96.3) in predicting lung cancer in CT-detected nodules. The PPV was 97.6%, and the NPV was 54.6%. Performance was consistent across gender (sensitivity 79.3% in men and 76.8% in women) and age groups, with a specificity of 93.4% in men and 92.7% in women. Stage I lung cancer was detected with a sensitivity of 80.6%. Conclusions: The Lung Cancer test based on 9G technology presented here offers a non-invasive method for stratifying lung cancer risk in patients with CT-detected nodules. Its integration into clinical practice could reduce unnecessary interventions and foster earlier detection. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
20726694
Volume :
16
Issue :
22
Database :
Academic Search Index
Journal :
Cancers
Publication Type :
Academic Journal
Accession number :
181171108
Full Text :
https://doi.org/10.3390/cancers16223737