Fibrotic Interstitial Lung Disease Early Recognition and Strategic Therapy Study in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Clinical diagnostic protocol of ILD tissue biopsy
研究概览
简要总结
This project aimed to: 1) construct a cohort of no less than 10000 cases of f-ILD (including pneumoconiosis ≥3000 cases) with continuous regular follow-up to reveal the clinical phenotypes closely related to the development, progression and prognosis of pulmonary fibrosis; 2) systematically evaluate the safety and effectiveness of frozen lung biopsy, surgical lung biopsy/thoracoscopic lung biopsy and other techniques, and to optimize the histological diagnosis method of f-ILD; 3) construct a set of artificial intelligence (AI) evaluation system for quantitative evaluation of pulmonary fibrosis and its severity, and develop application software; 4) excavate and verify important molecular targets for the formation of pulmonary fibrosis and identify biomarkers; 5) combined with clinical phenotype, imaging, pathology and biomarkers to establish f-ILD early recognition and progress model, intervention strategies, guidelines and consensus, and applicated nationwide.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as ILD
排除标准
- •Lack of chest CT
- •Patients refused to participant
结局指标
主要结局
Clinical diagnostic protocol of ILD tissue biopsy
时间窗: 3 years
Report on the reliability and safety assessment of TBLC and SLB diagnostics.
Predict model
时间窗: 3 years
The contents were based on the f-ILD cohort, combined with clinical, imaging, pathological, lung function and biomarker analysis, and constructed a multidimensional model for the early recognition and progression of f-ILD.
Severity of fibrosis in HRCT assessed by AI system in patients with ILD
时间窗: 3 years
Explore the diversity of abnormal image performance in patients with f-ILD, and extract multidimensional information based on deep learning and other methods. Realize the intelligent quantitative analysis of the severity of fibrosis.
F-ILD cohort
时间窗: 6 years
The researchers used inclusion/exclusion criteria for screening, and collected the demographic information, clinical symptoms and signs, laboratory tests, treatment, survival and other conditions of the patients who agreed to participate in the program and signed the informed consent, and collected biological specimens.
Important molecular targets and biomarkers identified by multi-omics
时间窗: 3 years
Single cell map of lung tissue in the early stage of ILD, key molecular targets and biomarkers for the development and progression of pulmonary fibrosis.
次要结局
未报告次要终点
研究者
Dai Huaping
Department of Pulmonary and Critical Care Medicine
China-Japan Friendship Hospital