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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

December 1, 2012

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed

Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

2.3 years

First QC Date

September 11, 2015

Last Update Submit

September 11, 2015

Conditions

Interstitial Lung Diseases

Keywords

Interstitial Lung Diseasesnanoparticleslungbroncho-alveolar lavagebronchial washings

Outcome Measures

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).
day 1

Secondary Outcomes (3)

Correlation between NP load in the lung and observed lung interstitial diseases
Day 1
Correlation between NP load in the lung and NP load in blood specimen
Day 1
Correlation between NP load in the lung and NP load in urine specimen
Day 1

Study Arms (2)

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: BALOther: BWOther: EACOther: blood specimenOther: 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: BALOther: BWOther: EACOther: blood specimenOther: Urine specimen