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

NCT ID: NCT02978131

Last Updated: 2019-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with a clinical diagnosis of TB

Patients with a clinical diagnosis of TB. Retrospective study on biopsy samples

Histopathological study

Intervention Type OTHER

Molecular study (Polymerase chain reaction)

Intervention Type OTHER

Interventions

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Histopathological study

Intervention Type OTHER

Molecular study (Polymerase chain reaction)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Positive TB patients
* Patients who performed biopsy before inclusion

Exclusion Criteria

* Anti-tuberculosis drugs administered before biopsy
* Patients who refuse to participate
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colette Creusy, MD

Role: PRINCIPAL_INVESTIGATOR

GHICL

Other Identifiers

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OBS-032

Identifier Type: -

Identifier Source: org_study_id

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