Comparison of Characteristics of Bronchoalveolar Lavage Dusting and of Specific Questionnary Data in Healthy Volunteers and Patients Suffering From Sarcoidosis (MINASARC01)

August 10, 2016 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon

MINASARC01: Comparison of Characteristics of Bronchoalveolar Lavage Dusting and of Specific Questionnary Data in Healthy Volunteers and Patients Suffering From Sarcoidosis: Pilot Study, Prospective, Multicenter, Multidisciplinary With Blind Analysis

Comparison of dusting rate of bronchoalveolar lavage in healthy volunteers and patients suffering from sarcoidosis.

Blind analysis of bronchoalveolar lavage with Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis.

For patients, comparison of bronchoalveolar lavage, pathological examination of biopsies (Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis) and specific Professional and environmental questionnary.

Healthy volunteers matched with patients regarding to age (every 10 years), sex and tobacco consumption (non-smoking, smoking less than 5 pack-year, smoking between 5 and 10 pack-year, smoking more than 10 pack-year)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Absence of respiratory and cardiac illness (healthy volunteers)
  • Normal spirometry and chest x-ray (healthy volunteers)
  • Absence of viral infection (B and C hepatitis, HIV) (healthy volunteers)
  • Confirmation of sarcoidosis (endoscopic exam with bronchoalveolar lavage) (patients suffering from sarcoidosis)

Exclusion Criteria:

  • Pregnant women
  • Lack of bronchoalveolar lavage (volume less than 20 ml)

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

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
Bronchoalveolar lavage in healthy volunteers
Other: Bronchoalveolar lavage
Bronchoalveolar lavage in order to determine rate of dust
Experimental: Patients suffering from sarcoidosis
Bronchoalveolar lavage in patients suffering from sarcoidosis
Other: Bronchoalveolar lavage
Bronchoalveolar lavage in order to determine rate of dust

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant difference between dusting rate of bronchoalveolar lavage in healthy volunteers and patients suffering from sarcoidosis (analysis by Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis).
Time Frame: Procedure of bronchoalveolar lavage
Procedure of bronchoalveolar lavage

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between mineral overload of bronchoalveolar lavage for patient suffering from sarcoidosis and data extracted from specific Professional and environmental questionnary
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Correlation between mineral overload of bronchoalveolar lavage for patient suffering from sarcoidosis and pathological examination of biopsies (analysis by Optical Microscopy, Transmission Electron Microscopy and MicroAnalysis).
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Interest of macrophagic dusting index
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Collaborators

Sciences Po Paris

Investigators

  • Principal Investigator: Michel Vincent, MD, Centre Hospitalier Saint Joseph Saint Luc

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

February 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MINASARC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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