Labial Biopsy in Patients With Tuberculosis Disease

April 15, 2014 updated by: Stephane Mouly, MD PhD, Hopital Lariboisière

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Unite de Recherche Thérapeutique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

bacteriologically confirmed tuberculosis

Description

Inclusion Criteria:

  • adults above 18 years,
  • bacteriologically confirmed tuberculosis

Exclusion Criteria:

  • patient not able to sign written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
bacteriologically confirmed tuberculosis
Other: labial biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence of granuloma on labial biopsy
Time Frame: at day zero of treatment of tuberculosis
at day zero of treatment of tuberculosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Lariboisière

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (ESTIMATE)

April 16, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 15, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • granuloma1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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