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

Primary Purpose

Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bronchoalveolar lavage
Sponsored by
Centre Hospitalier Saint Joseph Saint Luc de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcoidosis focused on measuring Dust rate, Microscopic analysis

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Healthy volunteers

    Patients suffering from sarcoidosis

    Arm Description

    Bronchoalveolar lavage in healthy volunteers

    Bronchoalveolar lavage in patients suffering from sarcoidosis

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Correlation between mineral overload of bronchoalveolar lavage for patient suffering from sarcoidosis and data extracted from specific Professional and environmental questionnary
    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).
    Interest of macrophagic dusting index

    Full Information

    First Posted
    July 5, 2016
    Last Updated
    August 10, 2016
    Sponsor
    Centre Hospitalier Saint Joseph Saint Luc de Lyon
    Collaborators
    Sciences Po Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02863406
    Brief Title
    Comparison of Characteristics of Bronchoalveolar Lavage Dusting and of Specific Questionnary Data in Healthy Volunteers and Patients Suffering From Sarcoidosis
    Acronym
    MINASARC01
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Saint Joseph Saint Luc de Lyon
    Collaborators
    Sciences Po Paris

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcoidosis
    Keywords
    Dust rate, Microscopic analysis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy volunteers
    Arm Type
    Experimental
    Arm Description
    Bronchoalveolar lavage in healthy volunteers
    Arm Title
    Patients suffering from sarcoidosis
    Arm Type
    Experimental
    Arm Description
    Bronchoalveolar lavage in patients suffering from sarcoidosis
    Intervention Type
    Other
    Intervention Name(s)
    Bronchoalveolar lavage
    Intervention Description
    Bronchoalveolar lavage in order to determine rate of dust
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    Interest of macrophagic dusting index
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michel Vincent, MD
    Organizational Affiliation
    Centre Hospitalier Saint Joseph Saint Luc
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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