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

Sarcoidosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863406
• Other study ID #: MINASARC01
• Status: Completed
• Phase: N/A
• First received: July 5, 2016
• Last updated: August 10, 2016
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Other:
• Bronchoalveolar lavage
Bronchoalveolar lavage in order to determine rate of dust

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon	Sciences Po Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Procedure of bronchoalveolar lavage	No
Secondary	Correlation between mineral overload of bronchoalveolar lavage for patient suffering from sarcoidosis and data extracted from specific Professional and environmental questionnary		Through study completion, an average of 1 year	No
Secondary	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).		Through study completion, an average of 1 year	No
Secondary	Interest of macrophagic dusting index		Through study completion, an average of 1 year	No