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

NCT02978131 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2019-03-20

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Histopathological study

OTHER

Molecular study (Polymerase chain reaction)

Sponsors & Collaborators

  • Lille Catholic University

    lead OTHER

Principal Investigators

  • Colette Creusy, MD · GHICL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-06-30
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02978131 on ClinicalTrials.gov