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

NCT02978131 | Completed

• 1 other identifier: OBS-032
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

TUBERCULOSIS; Sensitivity and Specificity; Polymerase Chain Reaction; Immunohistochemistry; Histochemistry; Paraformaldehyde and paraffin embedded tissues

Outcome Measures

Primary Outcomes (1)

• Number of positive TB cases with different techniques

  at inclusion

Study Arms (1)

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

Histopathological study OTHER

Patients with a clinical diagnosis of TB

Molecular study (Polymerase chain reaction) OTHER

Patients with a clinical diagnosis of TB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Positive TB patients

You may not qualify if:

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

Sponsors & Collaborators

• Lille Catholic University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Pulmonary and extrapulmonary, paraformaldehyde fixed and paraffin embedded tissues

MeSH Terms

Conditions

Tuberculosis; Hypersensitivity

Interventions

Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Colette Creusy, MD

  GHICL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: November 30, 2016
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share