NCT02863406

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
Last Updated

August 11, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

July 5, 2016

Last Update Submit

August 10, 2016

Conditions

Sarcoidosis

Keywords

Dust rateMicroscopic analysis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • 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

  • Interest of macrophagic dusting index

    Through study completion, an average of 1 year

Study Arms (2)

Healthy volunteers

EXPERIMENTAL

Bronchoalveolar lavage in healthy volunteers

Other: Bronchoalveolar lavage

Patients suffering from sarcoidosis

EXPERIMENTAL

Bronchoalveolar lavage in patients suffering from sarcoidosis

Other: Bronchoalveolar lavage

Interventions

Bronchoalveolar lavageOTHER

Bronchoalveolar lavage in order to determine rate of dust

Healthy volunteersPatients suffering from sarcoidosis

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcoidosis

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • Michel Vincent, MD

    Centre Hospitalier Saint Joseph Saint Luc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

August 11, 2016

Study Start

February 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share