Labial Biopsy in Patients With Tuberculosis Disease | NCT02115854

Studies
Labial Biopsy in Patients With Tuberculosis Disease

NCT02115854

Sponsor

Hopital Lariboisière

Status

Completed

Last Update Posted

Apr 16, 2014Estimated

Enrollment

65Actual

Phase

Not provided

Conditions

Tuberculosis
Sarcoidosis

Interventions

labial biopsy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Apr 2014Actual

Completion Date

Not provided

First Submitted Date

Apr 10, 2014

First Submission Date that Met QC Criteria

Apr 15, 2014

First Posted Date

Apr 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2014

Last Update Posted Date

Apr 16, 2014Estimated

Description Module

Brief 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.

The goal was to evaluate prospectively and consecutively the presence of epithelioid granulomas in salivary glands biopsy of patients with TB.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Label	Type	Description	Intervention Names
bacteriologically confirmed tuberculosis			Other: labial biopsy

Name	Type	Description	Arm Group Labels	Other Names
labial biopsy	Other		bacteriologically confirmed tuberculosis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults above 18 years,
bacteriologically confirmed tuberculosis

Exclusion Criteria:

patient not able to sign written consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

bacteriologically confirmed tuberculosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unite de Recherche Thérapeutique		Paris		75010	France

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis
D012507	Sarcoidosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided