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CompletedNCT02978131Updated Mar 20, 2019

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

An observational study in Tuberculosis, Diagnostic Techniques and Procedures and Sensitivity and Specificity, sponsored by Lille Catholic University. Completed. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Lille Catholic University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
20
Sex
All
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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.

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Conditions studied

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

Keywords

  • TUBERCULOSIS
  • Sensitivity and Specificity
  • Polymerase Chain Reaction
  • Immunohistochemistry
  • Histochemistry
  • Paraformaldehyde and paraffin embedded tissues
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In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 20 is below the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Lille Catholic University is the lead sponsor of 111 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Positive TB patients
  • Patients who performed biopsy before inclusion

Exclusion criteria

Exclusion Criteria:

  • Anti-tuberculosis drugs administered before biopsy
  • Patients who refuse to participate
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with a clinical diagnosis of TB

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

    Other: Histopathological study · Other: Molecular study (Polymerase chain reaction)

Interventions

  • OtherHistopathological study
  • OtherMolecular study (Polymerase chain reaction)
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What researchers measure

Primary outcomes

  1. Number of positive TB cases with different techniques

    Time frame: at inclusion

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02978131
Lead sponsor
Lille Catholic University
Responsible party
Sponsor
First posted
Nov 30, 2016
Start date
May 2015
Primary completion
Jun 2016
Completion
Jun 2017
Last update
Mar 20, 2019

Study contacts

Colette Creusy, MD
principal investigator · GHICL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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