Trials / Completed
CompletedNCT02978131
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- Lille Catholic University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Tuberculosis
- Diagnostic Techniques and Procedures
- Sensitivity and Specificity
- Polymerase Chain Reaction
- Immunohistochemistry
- Histochemistry
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Histopathological study | |
| OTHER | Molecular study (Polymerase chain reaction) |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2016-06-01
- Completion
- 2017-06-01
- First posted
- 2016-11-30
- Last updated
- 2019-03-20
Source: ClinicalTrials.gov record NCT02978131. Inclusion in this directory is not an endorsement.