- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02549248
Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology (NANOPI)
Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology. A Monocentric Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Saint-Etienne, Frankrig, 42055
- CHU Saint-Etienne
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
- " Test group ": patients suffering from idiopathic interstitial lung diseases including sarcoidosis and idiopathic pulmonary fibrosis.
- " 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.
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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. |
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
Patients with idiopathic and non idiopathic interstitial lung diseases
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. |
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
Patients with idiopathic and non idiopathic interstitial lung diseases
Patients with idiopathic and non idiopathic interstitial lung diseases
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
NP load
Tidsramme: 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). |
day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation between NP load in the lung and observed lung interstitial diseases
Tidsramme: 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. |
Day 1
|
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Correlation between NP load in the lung and NP load in blood specimen
Tidsramme: 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.
|
Day 1
|
|
Correlation between NP load in the lung and NP load in urine specimen
Tidsramme: 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.
|
Day 1
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jean-Michel VERGNON, PhD, CHU Saint-Etienne
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1008122
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