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

11. september 2015 oppdatert av: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Faktiske)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Saint-Etienne, Frankrike, 42055
        • CHU Saint-Etienne

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jean-Michel VERGNON, PhD, CHU Saint-Etienne

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2012

Primær fullføring (Faktiske)

1. april 2015

Studiet fullført (Faktiske)

1. april 2015

Datoer for studieregistrering

Først innsendt

11. september 2015

Først innsendt som oppfylte QC-kriteriene

11. september 2015

Først lagt ut (Anslag)

15. september 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. september 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2015

Sist bekreftet

1. september 2015

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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