- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Saint-Etienne, Frankrike, 42055
- CHU Saint-Etienne
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
- " 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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jean-Michel VERGNON, PhD, CHU Saint-Etienne
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1008122
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