IL-8+ naïve T Cells as a Biomarker for Thymoma Identification: A Prospective, Multi-center Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- The sensitivity of levels of IL-8+ initial T cells in the diagnosis of thymoma
研究概览
简要总结
According to the existing literature reports, the misdiagnosis rate of CT is as high as 22% - 68%. Thymic cyst and lymphoma are usually misdiagnosed as thymoma, resulting in many unnecessary operations; In addition, traditional imaging technologies can also cause a missed diagnosis rate of about 7%, which is common in the missed diagnosis of asymptomatic thymoma, which delays the opportunity of treatment. Therefore, in order to accurately treat thymic tumors, the existing diagnostic methods of thymic tumors need to be further optimized.
Our previous retrospective study found that the level of IL-8 + initial T cells can well distinguish thymoma from other types of anterior mediastinal tumors, and the sensitivity and specificity are close to 95%.
详细描述
This study is a prospective, multicenter diagnostic accuracy study. 310 patients with anterior mediastinal space occupying lesions who meet the enrollment conditions are planned to be recruited continuously. 5ml peripheral venous blood of the patients is taken before surgery or puncture biopsy and sent to the laboratory for blind detection of IL-8 + initial T cell level; Then the patient underwent anterior mediastinal tumor surgery or biopsy to obtain pathological results (gold standard for diagnosis). After the pathological results were confirmed, all cases were divided into thymoma group and non thymoma group. The sensitivity and specificity of IL-8 + initial T cells in the diagnosis of thymoma and the cutoff value of thymoma were calculated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Adult, aged 18 and above；
- •Patients with anterior mediastinal mass on imaging (chest CT or MRI)；
- •The patient's anterior mediastinal mass can be diagnosed by biopsy or surgery.
排除标准
- •Adolescents and children under the age of 18;
- •The patient's anterior mediastinal mass can not be diagnosed by biopsy or surgery.
结局指标
主要结局
The sensitivity of levels of IL-8+ initial T cells in the diagnosis of thymoma
时间窗: Through study completion, an average of 2 year
The specificity of levels of IL-8+ initial T cells in the diagnosis of thymoma
时间窗: Through study completion, an average of 2 year
The cutoff value of levels of IL-8+ initial T cells in the diagnosis of thymoma
时间窗: Through study completion, an average of 2 year
次要结局
- The specificity of levels of CR2+ initial T cells in the diagnosis of thymoma(Through study completion, an average of 2 year)
- The sensitivity of levels of PTK7+ initial T cells in the diagnosis of thymoma(Through study completion, an average of 2 year)
- The specificity of levels of PLXND1+ initial T cells in the diagnosis of thymoma(Through study completion, an average of 2 year)
- The sensitivity of levels of PLXND1+ initial T cells in the diagnosis of thymoma(Through study completion, an average of 2 year)
- The specificity of levels of PTK7+ initial T cells in the diagnosis of thymoma(Through study completion, an average of 2 year)
- The sensitivity of levels of IL-8+, PLXND1+, PTK7+ and/or CR2+ initial T cells combined with enhanced CT/MRI in the diagnosis of thymoma(Through study completion, an average of 2 year)
- The sensitivity of levels of CR2+ initial T cells in the diagnosis of thymoma(Through study completion, an average of 2 year)
- The specificity of enhanced CT/MRI in the diagnosis of thymoma(Through study completion, an average of 2 year)
- The sensitivity of enhanced CT/MRI in the diagnosis of thymoma(Through study completion, an average of 2 year)