NL-OMON56954尚未招募不适用
Early identification of progressive pulmonary fibrosis Precision Medicine for more Oxygen - ILD extension - P4O2 ILD extension
Amsterdam UMC0 个研究点目标入组 450 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •To be eligible to participate in this study, subjects must meet all of the
- •following criteria:
- •- IPF/FPF diagnosis (non-stratified) within 1 year prior to screening, based on
- •the guidelines set by ATS/ERS/JRS/ALAT (Raghu et al., 2022)(Zhang & Newton,
- •2021). A chest HRCT should have been performed within 12 months prior to
- •screening, meeting the minimum requirements for IPF diagnosis by
- •multidisciplinary consultation consensus in the ILD-expertise center based on
- •HRCT or HRCT and lung biopsy if available. If no HRCT is available prior to
- •screening, it can be performed at the screening;
- •- Meeting all of the following criteria during the screening period:
- •1. FVC >=45% predicted for normal.
- •2. FEV1/FVC >=0.7.
- •3. DLco corrected for Hb >=40% predicted of normal.
- •- Able to provide written informed consent as approved by the independent
- •ethics committee;
- •- Able to undergo a CT scan and perform pulmonary function testing;
- •- Age >18 years and <80 years;
- •- Understanding the Dutch or English language.
- •- Fibrotic ILD diagnosis based on the ATS/ERS/JRS/ALAT guidelines, classified
- •into one of the four defined subgroups (chronic/fibrotic HP, iNSIP, CTD-ILD, or
- •unclassifiable ILD; non-stratified)(Raghu et al., 2020; Ryerson et al., 2013;
- •Shao et al., 2021; Travis et al., 2013). A chest HRCT should have been
- •performed within 12 months prior to screening, meeting the minimum requirements
- •for fILD diagnosis by multidisciplinary consultation consensus in the
- •ILD-expertise center based on HRCT or HRCT, serologic markers (e.g.,
- •antibodies, biomarkers), and/or BALF/ung biopsy (if available). If no HRCT is
- •available prior to screening, it can be performed at the screening;
- •- Minimum of 10% involvement of the lung parenchyma on HRCT and signs of
- •fibrosis, defined as traction bronchiectasis/bronchiolectasis, lobar volume
- •loss, and/or honeycombing (investigator-determined);
- •- Meeting all of the following criteria during the screening period:
- •1. FVC >=45% predicted for normal.
- •2. FEV1/FVC >=0.7.
- •3. DLco corrected for Hb >=40% predicted of normal.
- •- Able to provide written informed consent as approved by the independent
- •ethics committee;
- •- Able to undergo a CT scan and perform pulmonary function testing;
- •- Age >18 years and <80 years;
- •- Understanding the Dutch or English language.
- •Criteria BAL candidates Arm 2/ f-ILD-group:
- •- BAL at diagnosis available;
- •- Progression after 1 year of follow-up;
- •- No contra-indications for performing BAL e.g. allergies;
- •- Performance of BAL is low-risk estimated by clinical physician.
- •- ILA is defined according to the current guidelines set by the Fleischner
- •Society (Hatabu et al., 2020). A chest HRCT should have been performed within
- •12 months prior to screening, meeting the minimum requirements for ILA
- •diagnosis by multidisciplinary consultation consensus in the ILD-expertise
- •center based on HRCT only or HRCT and lung biopsy if available.
- •- Meeting all of the following criteria during the screening period:
- 另有 7 项未显示
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Combined pulmonary fibrosis and emphysema (CPFE) is defined by the
- •coexistence of pulmonary fibrosis and emphysema, as described in the latest
- •paper by Cottin et al. (2022). To meet the criteria for CPFE on high-resolution
- •computed tomography (HRCT), patients must exhibit: emphysema of any subtype,
- •characterized by well-demarcated areas of low attenuation delimited by a very
- •thin wall (<1 mm) or no wall, involving at least 5% of the total lung volume
- •and lung fibrosis of any subtype (Cottin et al., 2022).
- •- Chronic obstructive lung disease (COPD) with an FEV1/FVC <70%;
- •- Uncontrolled severe asthma;
- •- Active malignancy, except for squamous cell carcinoma of the skin, low-risk
- •breast cancer, and low-risk prostate cancer;
- •- Pregnancy or lactating.
- •- Combined pulmonary fibrosis and emphysema (CPFE) is defined by the
- •coexistence of pulmonary fibrosis and emphysema, as described in the latest
- •paper by Cottin et al. (2022). To meet the criteria for CPFE on high-resolution
- •computed tomography (HRCT), patients must exhibit: emphysema of any subtype,
- •characterized by well-demarcated areas of low attenuation delimited by a very
- •thin wall (<1 mm) or no wall, involving at least 5% of the total lung volume
- •and lung fibrosis of any subtype (Cottin et al., 2022).
- •- Chronic obstructive lung disease (COPD) with an FEV1/FVC <70%;
- •- Uncontrolled severe asthma;
- •- Active malignancy, except for squamous cell carcinoma of the skin, low-risk
- •breast cancer, and low-risk prostate cancer;
- •- Pregnancy or lactating.
- •- Combined pulmonary fibrosis and emphysema (CPFE) is defined by the
- •coexistence of pulmonary fibrosis and emphysema, as described in the latest
- •paper by Cottin et al. (2022). To meet the criteria for CPFE on high-resolution
- •computed tomography (HRCT), patients must exhibit: emphysema of any subtype,
- •characterized by well-demarcated areas of low attenuation delimited by a very
- •thin wall (<1 mm) or no wall, involving at least 5% of the total lung volume
- •and lung fibrosis of any subtype (Cottin et al., 2022).
- •- Chronic obstructive lung disease (COPD) with an FEV1/FVC <70%;
- •- Uncontrolled severe asthma;
- •- Active malignancy, except for squamous cell carcinoma of the skin, low-risk
- •breast cancer, and low-risk prostate cancer;
- •- Medical history with pulmonary related auto-immune diseases;
- •- Family history with familial fibrosis (FPF);
- •- Pregnancy or lactating.
- •Additional exclusion criteria for the subgroups (n=60):
- •- In a subgroup of participants from arm 2 (n=30) and arm 3 (n=30), who undergo
- •an (additional) immunological bronchoalveolar lavage (iBAL) procedure,
- •participants with absolute contra-indications to undergo bronchoscopy with iBAL
- •will be excluded. Absolute-contra-indications are allergies to lidocaine,
- •midazolam, or xylometazoline, acute myocardial ischemia, and hemodynamic
- •instability in accordance with the protocol Bronchoscopy with immunological BAL
- •(in Dutch: Bronchoscopie met immunologische B.A.L) of the Amsterdam UMC (added
- •in Appendix 15.2).
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