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

NCT06655090 | Recruiting DMC

• 1 other identifier: ChinaJapanFH006
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease (ILD)

Outcome Measures

Primary Outcomes (5)

• Clinical diagnostic protocol of ILD tissue biopsy

  Report on the reliability and safety assessment of TBLC and SLB diagnostics.

  3 years

• Predict model

  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.

  3 years

• Severity of fibrosis in HRCT assessed by AI system in patients with ILD

  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.

  3 years

• F-ILD cohort

  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.

  6 years

• Important molecular targets and biomarkers identified by multi-omics

  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.

  3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were selected during hospitalization from medical organization.

You may qualify if:

• Diagnosed as ILD

You may not qualify if:

• Lack of chest CT
• Patients refused to participant

Sponsors & Collaborators

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

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Huaping Dai, M.D. Ph.D.

  China-Japan Friendship Hospital

  STUDY DIRECTOR

Central Study Contacts

Huaping Dai, M.D. Ph.D.

CONTACT

0086-10-84206271; daihuaping@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: October 23, 2024
• Study Start: December 1, 2021
• Primary Completion: November 30, 2024
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 23, 2024

Record last verified: 2024-07

Locations

CN (1)