Histopathological Techniques and PCR on Tissues Included in Paraffin for the Diagnosis of Tuberculosis
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
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.
研究概览
地位
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Positive TB patients
- Patients who performed biopsy before inclusion
Exclusion Criteria:
- Anti-tuberculosis drugs administered before biopsy
- Patients who refuse to participate
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Patients with a clinical diagnosis of TB
Patients with a clinical diagnosis of TB.
Retrospective study on biopsy samples
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Number of positive TB cases with different techniques
大体时间:at inclusion
|
at inclusion
|
合作者和调查者
调查人员
- 首席研究员:Colette Creusy, MD、GHICL
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- OBS-032
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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Histopathological study的临床试验
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Hospital Clinic of BarcelonaUniversitat Politècnica de Catalunya; Institut Catala de Salut; Department of Health, Generalitat... 和其他合作者未知