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

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.

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease (ILD)

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Huaping Dai, M.D. Ph.D.; Phone Number: 0086-10-84206271; Email: daihuaping@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Huaping Dai, M.D. Ph.D; Phone Number: 0086-10-84206271; Email: daihuaping@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients were selected during hospitalization from medical organization.

Description

Inclusion Criteria:

• Diagnosed as ILD

Exclusion Criteria:

• Lack of chest CT
• Patients refused to participant

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dai Huaping
• Collaborators: Tongji Hospital; Shanghai Chest Hospital; The First Affiliated Hospital of Guangzhou Medical University; Shanghai Pulmonary Hospital, Shanghai, China; Jilin University; Nankai University; Institute of Basic Medical Sciences CAMS; National Institute for Occupational Health and Poison Control; Infervision Medical Technology Company Limited
• Investigators: Study Director: Huaping Dai, M.D. Ph.D., China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: ChinaJapanFH006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No