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OpenTrials
Completed

NCT Number: NCT02978131

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Positive TB patients
  • Patients who performed biopsy before inclusion

Exclusion criteria

  • Anti-tuberculosis drugs administered before biopsy
  • Patients who refuse to participate

Treatment and study plan

Histopathological study

Other

Molecular study (Polymerase chain reaction)

Other

Primary outcomes

  1. Number of positive TB cases with different techniques

    Time frame: at inclusion

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 30, 2016
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.