TuberculosisNCT02115854
Labial Biopsy in Patients With Tuberculosis Disease
An observational study of Tuberculosis and Sarcoidosis, run by Hopital Lariboisière at 1 site in France.
Trial summary
The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease successfully treated with high dose steroids is not straightforward and may delay the treatment choice by the physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Sarcoidosis
- What is being tested?
- labial biopsy
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Apr 2014
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: bacteriologically confirmed tuberculosis
Who may be able to join
- adults above 18 years,
- bacteriologically confirmed tuberculosis
Who cannot join
- patient not able to sign written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Labial Biopsy in 65 Patients With Tuberculosis Disease
The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease successfully treated with high dose steroids is not straightforward and may delay the treatment choice by the physician.
The goal was to evaluate prospectively and consecutively the presence of epithelioid granulomas in salivary glands biopsy of patients with TB.
- Conditions
- Tuberculosis, Sarcoidosis
- Being tested
- labial biopsy
- Keywords
- usefullness of labial biopsy to distinguish between tuberculosis and sarcoidosis
- Medical subject headings
- Tuberculosis, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
labial biopsyOther
| Study group | Role | What they receive |
|---|---|---|
| bacteriologically confirmed tuberculosis | Not described Receives: Other: labial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of granuloma on labial biopsy
Measured: at day zero of treatment of tuberculosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startDec 2010
- Primary completionApr 2014
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
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane Mouly, MD PhD, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115854
- Sponsor's protocol ID
- granuloma1
- Status last verified
- Apr 2014
- First submitted
- 10 Apr 2014
- Last updated
- 16 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Labial Biopsy in 65 Patients With Tuberculosis Disease
- ClinicalTrials.gov ID
- NCT02115854
- Acronym / sponsor ID
- granuloma1
- Conditions
- Tuberculosis, Sarcoidosis
- Keywords
- usefullness of labial biopsy to distinguish between tuberculosis and sarcoidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Apr 2014 (actual)
- First posted
- 16 Apr 2014 (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.
The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease successfully treated with high dose steroids is not straightforward and may delay the treatment choice by the physician.
The goal was to evaluate prospectively and consecutively the presence of epithelioid granulomas in salivary glands biopsy of patients with TB.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bacteriologically confirmed tuberculosis | – | Other: labial biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- bacteriologically confirmed tuberculosis
Key inclusion criteria (2 listed)
- adults above 18 years,
- bacteriologically confirmed tuberculosis
Key exclusion criteria (1 listed)
- patient not able to sign written consent
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 |
|---|---|---|
| labial biopsy | Other | bacteriologically confirmed tuberculosis |
Primary outcome
presence of granuloma on labial biopsy
Time frame: at day zero of treatment of tuberculosis
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 16 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Sarcoidosis, run by Hopital Lariboisière at 1 site in France.
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 1 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 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
presence of granuloma on labial biopsy (time frame: at day zero of treatment of tuberculosis). 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 16 Apr 2014.