Evaluation of the Sensitivity of Histopathological Techniques and Molecular Biology (PCR) on Tissues Fixed in Paraformaldehyde and Included in Paraffin for the Diagnosis of Tuberculosis in Current Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Number of positive TB cases with different techniques
研究概览
简要总结
Tuberculosis (TB) remains a major public health problem nowadays. About 30% of the world population is infected with Mycobacterium tuberculosis. There is an increase in the number of cases of classic tuberculosis in developing countries, even if number of cases are declining in developed countries. However, in developed countries this decrease is counterbalanced by the emergence of multidrug resistant (MDR) strains of the bacteria.
There are also latent forms (1/3 of the world population) of the infection that can be reactivated in one case out of ten. Each year, about 2 million people die of tuberculosis and 9 million new cases are identified, including about 500,000 cases of MDR TB.
The spread of this disease as well as the increasing number of cases of MDR tuberculosis, reinforce the need for research and development of strategies of diagnosis and management of this affection.
Nowadays, the culture is the gold standard for the TB diagnosis but this technique needs at least three weeks to be performed. The objective of this study is to evaluate the sensitivity and specificity of histopathological and molecular techniques (PCR) on paraformaldehyde fixed and embedded in paraffin tissues for a faster diagnosis of tuberculosis in current practice, in order to administrate an efficient treatment as soon as possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive TB patients
- •Patients who performed biopsy before inclusion
排除标准
- •Anti-tuberculosis drugs administered before biopsy
- •Patients who refuse to participate
结局指标
主要结局
Number of positive TB cases with different techniques
时间窗: at inclusion
次要结局
未报告次要终点
