CClinicalTrials.gg
CompletedNCT02549248NANOPIUpdated Sep 15, 2015

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

An observational study in Interstitial Lung Diseases, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Interstitial Lung Diseases

Keywords

  • Interstitial Lung Diseases
  • nanoparticles
  • lung
  • broncho-alveolar lavage
  • bronchial washings
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 100 is below the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Flexible bronchoscopy or BAL not possible.
  • Pregnant women
  • Patients under legal protection.
  • Patients with contagious disease (HIV infection, tuberculosis, viral hepatitis)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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 · Other: BW · Other: EAC · Other: blood specimen · Other: Urine specimen

  • 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 · Other: BW · Other: EAC · Other: blood specimen · Other: Urine specimen

Interventions

  • OtherBAL

    Patients with idiopathic and non idiopathic interstitial lung diseases

  • OtherBW

    Patients with idiopathic and non idiopathic interstitial lung diseases

  • OtherEAC

    Patients with idiopathic and non idiopathic interstitial lung diseases

  • Otherblood specimen

    Patients with idiopathic and non idiopathic interstitial lung diseases

  • OtherUrine specimen

    Patients with idiopathic and non idiopathic interstitial lung diseases

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: day 1

Secondary outcomes

  1. 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.

    Time frame: Day 1

  2. 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.

    Time frame: Day 1

  3. 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.

    Time frame: Day 1

07

Study locations

1 site
  • Chu Saint-Etienne
    Saint-Etienne, 42055, France
08

References and documents

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. PubMed 34564355 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02549248
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Sep 15, 2015
Start date
Dec 2012
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Sep 15, 2015

Study contacts

Jean-Michel VERGNON, PhD
principal investigator · CHU Saint-Etienne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion