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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT02549248
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 28
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Diseases	Other: BAL; Other: BW; Other: EAC; Other: blood specimen; Other: Urine specimen

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology. A Monocentric Study
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. NP load [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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Saint-Etienne	Saint-Etienne		France	42055

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Jean-Michel VERGNON, PhD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT02549248
• Other Study ID Numbers: 1008122
• First Posted: Sep 15, 2015
• Last Update Posted: Sep 15, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: Interstitial Lung Diseases; nanoparticles; lung; broncho-alveolar lavage; bronchial washings
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Interstitial

Study Results

No Results Posted as of Sep 15, 2015