NCT04370158

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

4.5 years

First QC Date

April 29, 2020

Last Update Submit

April 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Database and biological sample library for Chinese patients with interstitial lung disease

    Data analyses will be mainly descriptive.

    up to 4 years

Interventions

Clinical progression and prognosis of patients with interstitial lung diseases

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the hospitals involved in this study

You may qualify if:

  • Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011
  • Agree to sign the informed consent

You may not qualify if:

  • Lung transplantation expected within the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huaping Dai

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (1)

  • Wang H, Liu A, Ni Y, Wang J, Du J, Xi L, Qiang Y, Xie B, Ren Y, Wang S, Geng J, Deng Y, Huang S, Zhang R, Liu M, Dai H; China Interstitial Lung Disease Collaboration Network. Developing and Validation of a Multimodal-Based Machine Learning Model for Diagnosis of Usual Interstitial Pneumonia: A Prospective Multicenter Study. Chest. 2025 Sep 16:S0012-3692(25)05248-1. doi: 10.1016/j.chest.2025.08.034. Online ahead of print.

Biospecimen

Retention: SAMPLES WITH DNA

Blood, BALF, lung tissue, fibroblast

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Center for Respiratory Diseases

Study Record Dates

First Submitted

April 29, 2020

First Posted

April 30, 2020

Study Start

July 1, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 30, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations