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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02549248
Acronym
NANOPI
Enrollment
100
Registered
2015-09-15
Start date
2012-12-31
Completion date
2015-04-30
Last updated
2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Diseases

Keywords

Interstitial Lung Diseases, nanoparticles, lung, broncho-alveolar lavage, bronchial washings

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.

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

Patients with idiopathic and non idiopathic interstitial lung diseases

Patients with idiopathic and non idiopathic interstitial lung diseases

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
NP loadday 1The 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).

Secondary

MeasureTime frameDescription
Correlation between NP load in the lung and NP load in blood specimenDay 1The 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.
Correlation between NP load in the lung and NP load in urine specimenDay 1The 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.
Correlation between NP load in the lung and observed lung interstitial diseasesDay 1The 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026