- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Saint-Etienne, 프랑스, 42055
- CHU saint-Etienne
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
- " 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.
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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NP load
기간: day 1
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlation between NP load in the lung and observed lung interstitial diseases
기간: Day 1
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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
기간: Day 1
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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.
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Day 1
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Correlation between NP load in the lung and NP load in urine specimen
기간: Day 1
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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.
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Day 1
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jean-Michel VERGNON, PhD, CHU saint-Etienne
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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