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

Interstitial Lung Diseases Clinical Trial

— NANOPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549248
• Other study ID #: 1008122
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: September 11, 2015
• Start date: December 2012
• Est. completion date: April 2015

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Interstitial Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• BAL
Patients with idiopathic and non idiopathic interstitial lung diseases
• BW
Patients with idiopathic and non idiopathic interstitial lung diseases
• EAC
Patients with idiopathic and non idiopathic interstitial lung diseases
• blood specimen
Patients with idiopathic and non idiopathic interstitial lung diseases
• Urine specimen
Patients with idiopathic and non idiopathic interstitial lung diseases

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No