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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06655090
Enrollment
10000
Registered
2024-10-23
Start date
2021-12-01
Completion date
2027-11-30
Last updated
2024-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease (ILD)

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.

Interventions

None listed

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
CollaboratorOTHER
Nankai University
CollaboratorOTHER
Jilin University
CollaboratorOTHER
Shanghai Pulmonary Hospital, Shanghai, China
CollaboratorOTHER
Shanghai Chest Hospital
CollaboratorOTHER
Institute of Basic Medical Sciences CAMS
CollaboratorUNKNOWN
Tongji Hospital
CollaboratorOTHER
National Institute for Occupational Health and Poison Control
CollaboratorUNKNOWN
Infervision Medical Technology Company Limited
CollaboratorUNKNOWN
Dai Huaping
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Diagnosed as ILD

Exclusion criteria

* Lack of chest CT * Patients refused to participant

Design outcomes

Primary

MeasureTime frameDescription
Clinical diagnostic protocol of ILD tissue biopsy3 yearsReport on the reliability and safety assessment of TBLC and SLB diagnostics.
Predict model3 yearsThe 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 ILD3 yearsExplore 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 cohort6 yearsThe 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-omics3 yearsSingle cell map of lung tissue in the early stage of ILD, key molecular targets and biomarkers for the development and progression of pulmonary fibrosis.

Countries

China

Contacts

Primary ContactHuaping Dai, M.D. Ph.D.
daihuaping@sina.com0086-10-84206271

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026