Evaluation of TB-antigen Responsive T Cell Markers in Diagnosis of Tuberculosis and Extrapulmonary Tuberculosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Positive rate and negative rate
研究概览
简要总结
Diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China. This observational study aims to evaluate TB-antigen responsive T cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt and cost-effective laboratory tests for active TB screening.
详细描述
The enrolled patients will be grouped into active or latent tuberculosis according to the bacteriological evidence of TB. The TB-antigen responsive T cell markers will be examined. The performance of each T cell marker for the diagnosis of active TB will be systematically evaluated.
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
- 7 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •any patients suspicious of TB infection
- •TB culture and Xpert test required
- •Chest X-ray required
排除标准
- •anti-TB therapy before the sample collection.
结局指标
主要结局
Positive rate and negative rate
时间窗: 2-3 month after sampling
Evaluation of the positive rate and negative rate for each T cell marker
Receiver operating characteristic curve
时间窗: 2-3 month after sampling
The AUC of each T cell marker will be analyzed and compared
次要结局
未报告次要终点
研究者
Caicun Zhou
Director, Department of Thoracic Oncology
Tongji University