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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02978131
Other study ID # OBS-032
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2015
Est. completion date June 2017

Study information

Verified date March 2019
Source Lille Catholic University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2017
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Positive TB patients

- Patients who performed biopsy before inclusion

Exclusion Criteria:

- Anti-tuberculosis drugs administered before biopsy

- Patients who refuse to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Histopathological study

Molecular study (Polymerase chain reaction)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lille Catholic University

Outcome

Type Measure Description Time frame Safety issue
Primary Number of positive TB cases with different techniques at inclusion
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