TuberculosisNCT02978131
Histopathological Techniques and PCR on Tissues Included in Paraffin for the Diagnosis of Tuberculosis
An observational study of Tuberculosis and Diagnostic Techniques and Procedures, run by Lille Catholic University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis, Diagnostic Techniques and Procedures, Sensitivity and Specificity
- What is being tested?
- Histopathological study and Molecular study (Polymerase chain reaction)
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a clinical diagnosis of TB. Retrospective study on biopsy samples
Who may be able to join
- Positive TB patients
- Patients who performed biopsy before inclusion
Who cannot join
- Anti-tuberculosis drugs administered before biopsy
- Patients who refuse to participate
About this study
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
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.
Read more
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
- Being tested
- Histopathological study, Molecular study (Polymerase chain reaction)
- Keywords
- TUBERCULOSIS, Sensitivity and Specificity, Polymerase Chain Reaction, Immunohistochemistry, Histochemistry, Paraformaldehyde and paraffin embedded tissues
- Medical subject headings
- Tuberculosis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histopathological studyOther
Molecular study (Polymerase chain reaction)Other
| Study group | Role | What they receive |
|---|---|---|
| Patients with a clinical diagnosis of TB | Patients with a clinical diagnosis of TB. Retrospective study on biopsy samples Receives: Other: Histopathological study; Other: Molecular study (Polymerase chain reaction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of positive TB cases with different techniques
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colette Creusy, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978131
- Sponsor's protocol ID
- OBS-032
- Status last verified
- Mar 2019
- First submitted
- 28 Nov 2016
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02978131
- Acronym / sponsor ID
- OBS-032
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a clinical diagnosis of TB | – | Other: Histopathological study, Other: Molecular study (Polymerase chain reaction)Patients with a clinical diagnosis of TB. Retrospective study on biopsy samples |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a clinical diagnosis of TB. Retrospective study on biopsy samples
Key inclusion criteria (2 listed)
- Positive TB patients
- Patients who performed biopsy before inclusion
Key exclusion criteria (2 listed)
- Anti-tuberculosis drugs administered before biopsy
- Patients who refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histopathological study | Other | Patients with a clinical diagnosis of TB |
| Molecular study (Polymerase chain reaction) | Other | Patients with a clinical diagnosis of TB |
Primary outcome
Number of positive TB cases with different techniques
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colette Creusy, MD principal investigator
GHICL
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Diagnostic Techniques and Procedures, run by Lille Catholic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of positive TB cases with different techniques (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.