Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology (NANOPI)

Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology. A Monocentric Study

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Diseases
• Intervention / Treatment: Other: BAL; Other: BW; Other: EAC; Other: blood specimen; Other: Urine specimen

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Chu Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Idiopathic interstitial diseases; " Test group ": patients suffering from idiopathic interstitial lung diseases including sarcoidosis and idiopathic pulmonary fibrosis. Nanoparticles (NP) loads will be measured on Bronchoalveolar lavages (BAL), bronchial washings (BW), exhaled air condensates (EAC), blood specimen and urine specimen.	Other: BAL; Patients with idiopathic and non idiopathic interstitial lung diseases; Other: BW; Patients with idiopathic and non idiopathic interstitial lung diseases; Other: EAC; Patients with idiopathic and non idiopathic interstitial lung diseases; Other: blood specimen; Patients with idiopathic and non idiopathic interstitial lung diseases; Other: Urine specimen; Patients with idiopathic and non idiopathic interstitial lung diseases
Non idiopathic intertitial diseases; " 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. Nanoparticles (NP) loads will be measured on Bronchoalveolar lavages (BAL), bronchial washings (BW), exhaled air condensates (EAC), blood specimen and urine specimen.	Other: BAL; Patients with idiopathic and non idiopathic interstitial lung diseases; Other: BW; Patients with idiopathic and non idiopathic interstitial lung diseases; Other: EAC; Patients with idiopathic and non idiopathic interstitial lung diseases; Other: blood specimen; Patients with idiopathic and non idiopathic interstitial lung diseases; Other: Urine specimen; Patients with idiopathic and non idiopathic interstitial lung diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NP load	The load of NP is a composite outcome. It will be described according to their level of presence (high, moderate or low), their size and chemical analysis. Analysis: The presence of NP will be assessed by dynamic light scattering (DLS). The elemental compositions of both the particulate (pellet) and the soluble (supernatant) fractions of each sample will be measured by means of inductively coupled plasma optical emission spectroscopy (ICP-OES). The samples for which DLS and ICP-OES corroborated a relatively stronger NP load will be observed under transmission electron microscopy (TEM) and field-emission electron microscopy (FESEM).	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between NP load in the lung and observed lung interstitial diseases	The load of NP is a composite outcome. It will be described according to their level of presence (high, moderate or low), their size and chemical analysis. The accurate diagnosis of the disease will be determined in accordance to the latest international guidelines, including the past history of each patient, the professional courses with focus on potential NP exposure, environmental studies, tobacco or drug use and exhaustive research of collagen or vascular diseases.	Day 1
Correlation between NP load in the lung and NP load in blood specimen	The load of NP is a composite outcome. It will be described according to their level of presence (high, moderate or low), their size and chemical analysis.	Day 1
Correlation between NP load in the lung and NP load in urine specimen	The load of NP is a composite outcome. It will be described according to their level of presence (high, moderate or low), their size and chemical analysis.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Jean-Michel VERGNON, PhD, Chu Saint-Etienne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Estimate): September 15, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: lung; nanoparticles; broncho-alveolar lavage; Interstitial Lung Diseases; bronchial washings
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 1008122