- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05367349
Optimising Screening for Early Disease Detection in Familial Pulmonary Fibrosis (FLORIS)
In this study the prognostic value of the current screening parameters for familial pulmonary fibrosis (FPF) will be investigated by looking at the screenings of 200 first-degree relatives of patients with FPF.
Also insight in the natural history of early FPF, and the necessary interval between screenings visits will be investigated.
연구 개요
상세 설명
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Jan Grutters, Prof.
- 전화번호: +31883201453
- 이메일: j.grutters@antoniusziekenhuis.nl
연구 연락처 백업
- 이름: Martijn Maus, MD
- 전화번호: +31883201467
- 이메일: m.maus@antoniusziekenhuis.nl
연구 장소
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Nieuwegein, 네덜란드, 3435CM
- 모병
- St Antonius hospital
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연락하다:
- Jan Grutters, Prof.
- 전화번호: +31883201453
- 이메일: j.grutters@antoniusziekenhuis.nl
-
연락하다:
- Martijn Maus, MD
- 전화번호: +31883201467
- 이메일: m.maus@antoniusziekenhuis.nl
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Asymptomatic first-degree relative of patients with familial pulmonary fibrosis (FPF)
Exclusion Criteria:
- A previous diagnosis of interstitial lung disease (ILD)
- Minors (aged <18 years)
- Pregnant
Note: woman who are pregnant at the start of the study or at the time of the HRCT are not allowed to participate. If a participant gets pregnant at a later stage during the study, she will not be excluded from the study. To be able to account for a potential effect of pregnancy during data analysis, female participants can be asked if they are pregnant at every visit.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Characteristics of participants
기간: Baseline
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Difference in age, sex, body weight, smoking history and comorbidities between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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Forced Vital Capacity (FVC)
기간: Baseline
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Difference in forced vital capacity (FVC) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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Haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc)
기간: Baseline
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Difference in haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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Total lung capacity (TLC)
기간: Baseline
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Difference in total lung capacity (TLC) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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Biomarker levels
기간: Baseline
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Difference in Krebs von den Lungen 6 (KL6), chemokine (C-C motif) ligand 18 (CCL18), surfactant protein-D (SP-D), matrix metalloproteinase 7 (MMP7) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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Oxygen saturation in 6-minute walk test (6MWT)
기간: Baseline
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Difference in oxygen saturation (rest in %), oxygen saturation (after 6MWT in %), oxygen saturation (nadir in %) and oxygen saturation (difference between rest and nadir in %) (all continuous variables) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
|
Baseline
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Distance (meters) in 6-minute walk test (6MWT)
기간: Baseline
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Difference in distance covered (in meters) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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MUC5B genotype
기간: Baseline
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Difference in MUC5B genotype (all discrete variables) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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Patient reported cough score
기간: Baseline
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Difference in visual analogue scale (VAS) for cough (scores between 0-100, with 100 being the worst) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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Patient reported dyspnea score
기간: Baseline
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Difference in medical research council (MRC) (scores between 0-5, with 5 being the worst) between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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Clubbing
기간: Baseline
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Difference in presence of digital clubbing between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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Crackles
기간: Baseline
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Difference in inspiratory crackles during lung auscultation between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Forced Vital Capacity (FVC)
기간: 2 years
|
Difference in forced vital capacity (FVC) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc)
기간: 2 years
|
Difference in haemoglobulin-corrected carbon monoxide diffusing capacity (DLCOc) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Total lung capacity (TLC)
기간: 2 years
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Difference in total lung capacity (TLC) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Biomarker levels
기간: 2 years
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Difference in KL6, CCL18, SP-D and MMP7 over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Genotype
기간: 2 years
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Difference in MUC5B genotype over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Oxygen saturation in 6-minute walk test (6MWT)
기간: 2 years
|
Difference in oxygen saturation (rest in %), oxygen saturation (after 6MWT in %), oxygen saturation (nadir in %) and oxygen saturation (difference between rest and nadir in %) (all continuous variables) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Distance (meters) in 6-minute walk test (6MWT)
기간: 2 years
|
Difference in distance covered (in meters) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Patient reported cough score
기간: 2 years
|
Difference in visual analogue scale (VAS) for cough (scores between 0-100, with 100 being the worst) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Patient reported dyspnea score
기간: 2 years
|
Difference in medical research council (MRC) (scores between 0-5, with 5 being the worst) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Digital clubbing
기간: 2 years
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Difference in presence of digital clubbing over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Crackles
기간: 2 years
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Difference in inspiratory crackles during lung auscultation over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Patient reported fatigue
기간: 2 years
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Difference in fatigue assessment scale (FAS) (scores range from 10-50, with 50 being the worst) over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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Patient reported health status
기간: 2 years
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Difference in EuroQol 5D-5L (EQ-5D-5L) (comprises of a score in five levels, level 1-5 with 5 being the worst, and a visual analoque scale ranging from 0-100 with 100 being the best) and the over the course of 2 years in the subjects with presence of ILD changes on enrollment HRCT and also between the group with ILD changes and the group without ILD changes present on enrollment HRCT
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2 years
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Relatedness
기간: Baseline
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In case multiple members of the same family are included in the study
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Baseline
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Blood count
기간: 2 years
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Blood count (Consisting of; hemoglobin (mmol/l), erythrocytes (x10^12/l), mean corpuscular volume (fl), red cell distribution width (%), thrombocytes (x10^9/l), leukocytes (x10^9/l)) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between bloodcount in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
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2 years
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Creatinin
기간: 2 years
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creatinin (umol/l) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between creatinin in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
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2 years
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Liver function tests
기간: 2 years
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Liver function tests (consisting of: ASAT (U/l), ALAT (U/l), alkaline phosphatase (U/l), Gamma-glutamyl transpeptidase (U/l)) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between these liver function tests in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
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2 years
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Total bilirubin
기간: 2 years
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Total bilirubin (umol/l) as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between total bilirubin in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
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2 years
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Additional blood based markers
기간: 2 years
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Additional blood based markers as an exploratory measurement in the subjects with presence of ILD changes on enrollment HRCT and the difference between these blood based markers in the subjects with presence of ILD changes on enrollment HRCT and the group without ILD changes present on enrollment HRCT
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2 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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