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NCT04370158 Clinical Trial

Interstitial Lung Diseases Cohort Study in China

Interstitial Lung Diseases Clinical Trial

— ILD-China  

Official title:
Interstitial Lung Diseases Cohort Study in China

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04370158
Other study ID # ChinaJapanFH003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2016
Est. completion date December 31, 2020

Study information
Verified date April 2020
Source China-Japan Friendship Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In this project, the clinical diagnosis of interstitial lung diseases was carried out for the population with suspected interstitial lung diseases selected from the community cohort, and the confirmed patients were included into the existing clinical cohort of interstitial lung diseases, forming an interstitial lung diseases special disease cohort consisting of 3,000 patients and corresponding matched control groups. According to characteristics of interstitial lung disease and the needs of National Key R&D Program of China, this study will formulate unified clinical follow-up strategy to do long-term standardized clinical follow-up in patients with interstitial lung disease. The detailed information for clinical diagnosis and treatment as well as biological samples were collected to identify disease phenotype and build the database and biological sample library for interstitial lung disease cohort study. This study aims to provide evidence for molecular classification, screening and validation of biomarkers as well as precise diagnosis and prevention in patients with interstitial lung disease.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011

- Agree to sign the informed consent

Exclusion Criteria:

- Lung transplantation expected within the next 6 months

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• disease history
Clinical progression and prognosis of patients with interstitial lung diseases

Locations
Country Name City State
China Huaping Dai Beijing Beijing

Sponsors (6)
Lead Sponsor Collaborator
China-Japan Friendship Hospital First Affiliated Hospital Guangzhou Medical University, First Hospital of China Medical University, Peking Union Medical College Hospital, The Fourth Affiliated Hospital of China Medical University, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Database and biological sample library for Chinese patients with interstitial lung disease Data analyses will be mainly descriptive. up to 4 years
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