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

11. september 2015 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Saint-Etienne, Frankrig, 42055
        • CHU Saint-Etienne

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Jean-Michel VERGNON, PhD, CHU Saint-Etienne

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2012

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

11. september 2015

Først indsendt, der opfyldte QC-kriterier

11. september 2015

Først opslået (Skøn)

15. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Interstitielle lungesygdomme

Kliniske forsøg med BAL

Abonner