Tuberculosis Clinical Trial
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
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 |
Verified date | March 2019 |
Source | Lille Catholic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lille Catholic University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of positive TB cases with different techniques | at inclusion |
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