Interstitial Lung DiseasesILD-ChinaNCT04370158
Interstitial Lung Diseases Cohort Study in China
An observational study of Interstitial Lung Diseases, run by China-Japan Friendship Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Interstitial Lung Diseases
- What is being tested?
- disease history
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 31 Dec 2020
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from the hospitals involved in this study
Who may be able to join
- Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011
- Agree to sign the informed consent
Who cannot join
- Lung transplantation expected within the next 6 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huaping Dai
Beijing, Beijing Municipality, 100029
Dai Huaping, 0086-10-84206271, daihuaping@sina.com
About this study
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.
- Conditions
- Interstitial Lung Diseases
- Being tested
- disease history
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disease historyOther
Clinical progression and prognosis of patients with interstitial lung diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Database and biological sample library for Chinese patients with interstitial lung disease
Data analyses will be mainly descriptive.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Jul 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseasesStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Xiangya Hospital of Central South University, First Hospital of China Medical University, The Fourth Affiliated Hospital of China Medical University, Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Dai Huaping, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370158
- Sponsor's protocol ID
- ChinaJapanFH003
- Acronym
- ILD-China
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meng W, Geng J, Chen X, Dai H. Serum CA125 is independently associated with adverse outcomes in primary Sjogren's syndrome-associated interstitial lung disease: a prospective multicenter cohort study. Respir Res. 2026 Feb 12;27(1):150. doi: 10.1186/s12931-026-03573-x.
PubMed 41673669Wang 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. 2026 Feb;169(2):415-427. doi: 10.1016/j.chest.2025.08.034. Epub 2025 Sep 16.
PubMed 40967367
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Lung Diseases Cohort Study in China
- ClinicalTrials.gov ID
- NCT04370158
- Acronym / sponsor ID
- ILD-China / ChinaJapanFH003
- Conditions
- Interstitial Lung Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Xiangya Hospital of Central South University, First Hospital of China Medical University, The Fourth Affiliated Hospital of China Medical University, Peking Union Medical College Hospital
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the hospitals involved in this study
Key inclusion criteria (2 listed)
- Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011
- Agree to sign the informed consent
Key exclusion criteria (1 listed)
- Lung transplantation expected within the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disease historyClinical progression and prognosis of patients with interstitial lung diseases | Other | – |
Primary outcome
Database and biological sample library for Chinese patients with interstitial lung disease
Time frame: up to 4 years
Data analyses will be mainly descriptive.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Derived from this study: PubMed 41673669Meng W, Geng J, Chen X, Dai H. Serum CA125 is independently associated with adverse outcomes in primary Sjogren's syndrome-associated interstitial lung disease: a prospective multicenter cohort study. Respir Res. 2026 Feb 12;27(1):150. doi: 10.1186/s12931-026-03573-x.
- Derived from this study: PubMed 40967367Wang 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. 2026 Feb;169(2):415-427. doi: 10.1016/j.chest.2025.08.034. Epub 2025 Sep 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Diseases, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Database and biological sample library for Chinese patients with interstitial lung disease (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.