Fibrotic Interstitial Lung Disease Early Recognition and Strategic Therapy Study in China

Recruiting

• Conditions: Interstitial Lung Disease (ILD)

• Registration Number: NCT06655090
• Lead Sponsor: Dai Huaping

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-06-28
• Status Verified: 2024-07
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-23
• Primary Completion: 2024-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Diagnosed as ILD

Exclusion Criteria

• Lack of chest CT
• Patients refused to participant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical diagnostic protocol of ILD tissue biopsy	3 years	Report on the reliability and safety assessment of TBLC and SLB diagnostics.
Predict model	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	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	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	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.

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China