Clinical trial NCT02549248: Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology
Official title: Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology. A Monocentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Diseases
Keywords: Interstitial Lung Diseases
nanoparticles
lung
broncho-alveolar lavage
bronchial washings
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * " Test group ": patients suffering from idiopathic interstitial lung diseases including sarcoidosis and idiopathic pulmonary fibrosis.
* " Control group ": patients suffering from interstitial lung diseases of known aetiologies, such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions.

Brief summary: Nanoparticles (NP) are particles whose length, width and height are less than 100 nanometres. Over the past decade, industrial applications of NP have increased dramatically. Despite their widespread use, their true impact on human health remains unknown and poorly studied. NP exposure in humans primarily occurs via inhalation through the respiratory system. The aim of this study is to estimate the relationships between the nanoparticle load in the lung and bronchi and some interstitial lung diseases. In the aftermath of human exposure to asbestos, the pathological consequences of environmental exposure to nanomaterials could be evaluated upon a mineralogical analysis of pulmonary samples.


Eligibility criteria: Inclusion Criteria:

* Patients with an interstitial lung disease assessed on clinical signs and CT scan, requiring a flexible bronchoscopy with a broncho-alveolar lavage.

These patients suffer from:

* Idiopathic interstitial lung diseases such as idiopathic pulmonary fibrosis or sarcoidosis OR
* Interstitial lung diseases of known aetiologies such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions.

Written consent

Exclusion Criteria:

* Flexible bronchoscopy or BAL not possible.
* Pregnant women
* Patients under legal protection.
* Patients with contagious disease (HIV infection, tuberculosis, viral hepatitis)

Primary outcomes:
measure: NP load
timeFrame: day 1
Secondary outcomes:
measure: Correlation between NP load in the lung and observed lung interstitial diseases
timeFrame: Day 1
measure: Correlation between NP load in the lung and NP load in blood specimen
timeFrame: Day 1
measure: Correlation between NP load in the lung and NP load in urine specimen
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Michel VERGNON, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forest V, Pourchez J, Pelissier C, Audignon Durand S, Vergnon JM, Fontana L. Relationship between Occupational Exposure to Airborne Nanoparticles, Nanoparticle Lung Burden and Lung Diseases. Toxics. 2021 Aug 30;9(9):204. doi: 10.3390/toxics9090204.