Cancer Hospital Chinese Academy of Medical Sciences
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Accuracy of subsolid nodule invasive diagnosis
研究概览
简要总结
Current clinical follow-up frequency and treatment timing for pulmonary subsolid nodules (SSNs) rely mostly on whether the nodules grow, which may not accurately reflect the pathological status, and may lead to unnecessary follow-ups. This study aims to use multi-omics techniques to dynamically observe the growth and invasiveness evolution process of SSNs and uncover its invasiveness mechanism. Radiological characteristics of SSNs in different invasiveness stages were also analyzed and summarized by analyzing preoperative CT. This can overcome the bottleneck of invasiveness assessment in the growth process of SSN and provide scientific evidence for the scientific management and clinical treatment timing choice of SSN patients, thus facilitating the rational allocation of medical resources and prolonging the expected survival of national health.
详细描述
This prospective observational cohort study aims to recruit 120 patients with subsolid nodules (SSNs) and 100 healthy volunteers. Enroll 120 patients with SSNs planned for surgery and 100 healthy volunteers. Sequence blood and tissue samples from patients and compare the relevance of biomarkers between the two. Use blood from healthy volunteers as blank controls. Additionally, analyzes radiological characteristics of SSNs at different invasive stages using preoperative CT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with SSNs
- •Newly diagnosed patients with persistent SSNs confirmed by thin-section chest CT examination
- •Patient areilling to undergo surgery
- •Voluntarily sign a written informed consent form
- •Healthy Volunteers
- •Healthy volunteers aged 18-50 years, regardless of gender.
- •No lung nodules detected on chest thin-section CT.
- •No history of cancer.
- •Voluntary sign a written informed consent form.
排除标准
- •Patients with SSNs
- •Surgical contraindications
- •Inability to cooperate with CT/MR examination to obtain high-quality images
- •History of malignant tumors
- •Previous targeted, immune, or ablation therapy
- •Postoperative pathology of non-lung adenocarcinoma disease spectrum
- •Other situations deemed unsuitable for participation in this study by the researchers
- •Healthy Volunteers
- •HIV infection or AIDS
- •History of syphilis, gonorrhea, or other infectious diseases
- •Hepatitis B or C virus carrier
结局指标
主要结局
Accuracy of subsolid nodule invasive diagnosis
时间窗: Through study completion, an average of 1 year.
The efficacy of screening features for SSN invasiveness was compared to pathological diagnosis, using metrics such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
次要结局
未报告次要终点