Early Adjuvant Diagnosis Clinical Trial of Pulmonary Nodules Based on Circulating Tumor Cells.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- sensitivity
研究概览
简要总结
The goal of this observational clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. The main questions it aims to answer is: the sensitivity and specificity of peripheral blood circulating tumor cell detection in differentiating benign and malignant pulmonary nodules (≤3cm). Participants will be asked provide 4mL of peripheral blood for the test.
详细描述
The aim of this clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. Patients with clinical suspected malignant pulmonary nodules will be included in this trial. Peripheral blood of participants will be collected before surgery or biopsy. Clinical and imaging data of enrolled patients will also be collected. Pathological diagnosis is the gold standard for differentiating benign and malignant pulmonary nodules. The sensitivity and specificity of CTC detection for diagnosing malignant pulmonary nodules will be analyzed.
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 single or multiple pulmonary nodules on CT imaging;
- •Subjects ≥18 years old, regardless of gender, occupation, and region, should have independent capacity for civil conduct and sign the informed consent for clinical study;
- •Subjects are generally in good condition, with ECOG score 0-1 and life expectancy of no less than 2 months;
- •Organ function level requirements:
- •Peripheral blood: 1.5 x 10^9/L≤ absolute neutrophil count (ANC) ≤15 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9.0 g/dL; Prothrombin time (PT) ≥11 seconds, International normalized ratio (INR) ≥0.8;
- •Bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal;
- •Serum creatinine ≤1.5 times the upper limit of normal value.
排除标准
- •The subjects had a history of malignant tumors, or serious cardiovascular and cerebrovascular diseases (had undergone heart stent surgery within 6 months or had been admitted to ICU, CCU or other intensive care units due to cardiovascular and cerebrovascular diseases, or EF≤50%); b. Severe vasculopathy, pulmonary tuberculosis or large-scale acute inflammation (including but not limited to acute bronchitis, vasculitis, etc.) or active chronic infection (HIV, HBV, HCV, etc.) within 3 months;
- •Poor compliance, unable to cooperate with the research program;
- •Participants in any drug trial within three months prior to enrollment;
- •Pregnant or breastfeeding;
- •Puncture/Surgical contraindications.
结局指标
主要结局
sensitivity
时间窗: until the samples are collected and tested as planned, up to 72 months
the ability of peripheral blood CTC count detection to identify malignant pulmonary nodules when the real condition is malignancy
specificity
时间窗: until the samples are collected and tested as planned, up to 72 months
the ability of peripheral blood CTC count detection to exclude malignant pulmonary nodules when the real condition is benign disease
次要结局
未报告次要终点
研究者
Guangying Zhu
chief physician
China-Japan Friendship Hospital