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Recruiting NCT06655090

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

— Observational Interstitial Lung Disease (ILD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Interstitial Lung Disease (ILD). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Clinical diagnostic protocol of ILD tissue biopsy [Time frame: 3 years]
  • Predict model [Time frame: 3 years]
  • Severity of fibrosis in HRCT assessed by AI system in patients with ILD [Time frame: 3 years]
  • F-ILD cohort [Time frame: 6 years]
  • Important molecular targets and biomarkers identified by multi-omics [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • Diagnosed as ILD

Exclusion criteria

  • Lack of chest CT
  • Patients refused to participant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Publications

  • Wang S, Zhang X, Xie B, Ren Y, Geng J, Luo S, He X, Jiang D, He J, Hu Y, Zhu L, Li J, Zhou G, Liu M, Zhao L, Dai H. Fibrotic Interstitial Lung Disease Early Recognition and Strategic Therapy Study in China (FIRST): protocol for a prospective, multicentre registry study. BMJ Open. 2025 Nov 5;15(11):e105980. doi: 10.1136/bmjopen-2025-105980. PMID 41198211

Identifiers

NCT: NCT06655090 · ChinaJapanFH006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗