Histopathological Techniques and PCR on Tissues Included in Paraffin for the Diagnosis of Tuberculosis

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Histochemistry, Tuberculosis, Diagnostic Techniques and Procedures, Sensitivity and Specificity, Polymerase Chain Reaction, Immunohistochemistry

Intervention / Treatment
-----------------
* Other: Histopathological study
* Other: Molecular study (Polymerase chain reaction)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive TB patients Patients who performed biopsy before inclusion Exclusion Criteria: Anti-tuberculosis drugs administered before biopsy Patients who refuse to participate
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with a clinical diagnosis of TB<br>Patients with a clinical diagnosis of TB. Retrospective study on biopsy samples | Other: Histopathological study<br> <br> Other: Molecular study (Polymerase chain reaction)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of positive TB cases with different techniques |  | at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Histochemistry, TUBERCULOSIS, Sensitivity and Specificity, Polymerase Chain Reaction, Immunohistochemistry, Paraformaldehyde and paraffin embedded tissues