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.
**背景与目的：** 胸部计算机断层扫描（CT）检出的肺结节通常需要通过侵入性活检来明确诊断，这导致良性病变患者接受了不必要的操作。一种基于血液的生物标志物检测，若能预测CT检出结节的肺癌风险，将有助于对患者进行风险分层，并将侵入性诊断手段导向高风险个体。 **方法：** 在这项多中心、单盲临床试验中，我们评估了一项检测，该检测测量了CT检出肺结节患者血浆中的p53蛋白、抗p53自身抗体、CYFRA 21-1蛋白和抗CYFRA 21-1自身抗体水平。计算了敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV），并按性别、年龄和吸烟状况进行了亚组分析。研究共纳入来自韩国两家学术医院的1132例CT检出肺结节患者，其中包括885例肺癌病例和247例良性病变。 **结果：** 该检测在预测CT检出结节为肺癌方面，显示出78.4%（95% CI: 75.7–81.1）的敏感性和93.1%（95% CI: 90.0–96.3）的特异性。PPV为97.6%，NPV为54.6%。检测性能在不同性别（男性敏感性79.3%，女性敏感性76.8%）和年龄组中表现一致，男性特异性为93.4%，女性特异性为92.7%。对于I期肺癌的检测敏感性为80.6%。 **结论：** 本文介绍的基于9G技术的肺癌检测为CT检出结节患者提供了一种非侵入性的肺癌风险分层方法。将其整合到临床实践中，可减少不必要的干预措施，并促进早期发现。
肿瘤(癌症)患者之家