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Completed

NCT Number: NCT02549248

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

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.

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Key information

Conditions

Interstitial Lung Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BAL

Other

Patients with idiopathic and non idiopathic interstitial lung diseases

BW

Other

Patients with idiopathic and non idiopathic interstitial lung diseases

EAC

Other

Patients with idiopathic and non idiopathic interstitial lung diseases

blood specimen

Other

Patients with idiopathic and non idiopathic interstitial lung diseases

Urine specimen

Other

Patients with idiopathic and non idiopathic interstitial lung diseases

Primary outcomes

  1. NP load

    Time frame: day 1

    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).

Secondary outcomes

  1. Correlation between NP load in the lung and observed lung interstitial diseases

    Time frame: Day 1

    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.

  2. Correlation between NP load in the lung and NP load in blood specimen

    Time frame: Day 1

    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.

  3. Correlation between NP load in the lung and NP load in urine specimen

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: NANOPI

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 15, 2015
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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