Idiopathic Pulmonary FibrosisPORTRAYNCT03666234
Idiopathic Pulmonary Fibrosis Registry China Study
An observational study of Idiopathic Pulmonary Fibrosis, run by Dai Huaping at 1 site in China.
Trial summary
By mean of registry of newly diagnosed Chinese IPF patients from more than 15 sites, this study aims to build IPF prospective cohort, set up normative clinical database and a biological specimen bank, and examine the clinical characteristics of newly diagnosed Chinese IPF patients, as well as the nature history… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 30 Jun 2023
- How long will I take part?
- 3 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese newly diagnosed IPF patients
Who may be able to join
- Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011
- Aged 40 years and above at recruitment
- Willing and able to sign an informed consent
- Lung transplantation expected within the next 6 months.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huaping Dai
Beijing, Beijing Municipality, 100029
Huaping Dai, 0086-13901293597, daihuaping@sina.com
About this study
By mean of registry of newly diagnosed Chinese IPF patients from more than 15 sites, this study aims to build IPF prospective cohort, set up normative clinical database and a biological specimen bank, and examine the clinical characteristics of newly diagnosed Chinese IPF patients, as well as the nature history, prognosis, comorbidities and complications of IPF patients in China, the current treatment pattern, burden of illness, and quality of life of Chinese IPF patients.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, Epidemiology, Nature History
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and clinical characteristic of newly diagnosed Chinese IPF patients
Data analyses will be mainly descriptive.
Measured: up to 5 years
Secondary outcomes (4)
Mortality in Chinese patients with IPF
Mortality will be showed as percentage.
Measured: up to 5 years
Cause of death in Chinese patients with IPF
Cause of death:
- IPF-related: i. Respiratory failure: Pulmonary failure leads to impaired gas exchange, i.e. hypoxemia and/or hypercapnia ii. Acute exacerbation of IPF (as defined below) iii. Other aspects related to IPF (please specify); b. Concomitant conditions: i. Coronary heart disease ii. Cerebrovascular disease iii. Pneumonia/respiratory tract infection iv. Pulmonary embolism v. Pulmonary hypertension or pulmonary hypertension/right heart failure vi. Lung cancer; c. Other causes; d. Unknown.
Cause of death will be showed as categorical variable, and the counts and percentile ratios will be statistically counted.
Measured: up to 5 years
Progression-free survival in Chinese patients with IPF
Patients without the following events:
- Death
- Lung transplantation
- Acute exacerbation
- Require long-term oxygen therapy
- Hospitalization for respiratory reasons
The unit of progression-free survival is day.
Measured: up to 5 years
Description of the acute exacerbations in Chinese patients with IPF
Acute exacerbation of IPF (AE-IPF)
- Previous diagnosis or simultaneous diagnosis of IPF;
- Symptoms generally manifest as dyspnea with acute exacerbations or progression within 1 month;
- Chest CT shows new bilateral glass ground or solid shadows on the basis of usual interstitial pneumonia (UIP);
- Exacerbations cannot be completely explained by heart failure or increased volume load.
The incidence of the acute exacerbation will be showed as percentage.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (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 Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- 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
- 800 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Dai Huaping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dai Huaping, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666234
- Sponsor's protocol ID
- ChinaJapanFH002
- Acronym
- PORTRAY
- Status last verified
- Sep 2018
- First submitted
- 20 Jun 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang X, Wang H, Liu A, Ni Y, Wang J, Han Y, Xie B, Geng J, Ren Y, Zhang R, Liu M, Dai H. Evaluation of respiratory muscle dysfunction in patients with idiopathic pulmonary fibrosis: a prospective observational study with magnetic resonance imaging. BMC Pulm Med. 2025 Mar 14;25(1):118. doi: 10.1186/s12890-025-03572-6.
PubMed 40087606Xie B, Ren Y, Geng J, He X, Ban C, Wang S, Jiang D, Luo S, Chen Q, Liu M, Feng R, Zhao L, Dai H, Wang C. Idiopathic Pulmonary Fibrosis Registry China study (PORTRAY): protocol for a prospective, multicentre registry study. BMJ Open. 2020 Nov 11;10(11):e036809. doi: 10.1136/bmjopen-2020-036809.
PubMed 33177132
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Pulmonary Fibrosis Registry China Study
- ClinicalTrials.gov ID
- NCT03666234
- Acronym / sponsor ID
- PORTRAY / ChinaJapanFH002
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, Epidemiology, Nature History
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Dai HuapingUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 11 Sep 2018 (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.
By mean of registry of newly diagnosed Chinese IPF patients from more than 15 sites, this study aims to build IPF prospective cohort, set up normative clinical database and a biological specimen bank, and examine the clinical characteristics of newly diagnosed Chinese IPF patients, as well as the nature history, prognosis, comorbidities and complications of IPF patients in China, the current treatment pattern, burden of illness, and quality of life of Chinese IPF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese newly diagnosed IPF patients
Key inclusion criteria (4 listed)
- Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011
- Aged 40 years and above at recruitment
- Willing and able to sign an informed consent
- Lung transplantation expected within the next 6 months.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic and clinical characteristic of newly diagnosed Chinese IPF patients
Time frame: up to 5 years
Data analyses will be mainly descriptive.
4 secondary outcomes
Mortality in Chinese patients with IPF
Time frame: up to 5 years
Cause of death in Chinese patients with IPF
Time frame: up to 5 years
Progression-free survival in Chinese patients with IPF
Time frame: up to 5 years
Description of the acute exacerbations in Chinese patients with IPF
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Derived from this study: PubMed 40087606Yang X, Wang H, Liu A, Ni Y, Wang J, Han Y, Xie B, Geng J, Ren Y, Zhang R, Liu M, Dai H. Evaluation of respiratory muscle dysfunction in patients with idiopathic pulmonary fibrosis: a prospective observational study with magnetic resonance imaging. BMC Pulm Med. 2025 Mar 14;25(1):118. doi: 10.1186/s12890-025-03572-6.
- Derived from this study: PubMed 33177132Xie B, Ren Y, Geng J, He X, Ban C, Wang S, Jiang D, Luo S, Chen Q, Liu M, Feng R, Zhao L, Dai H, Wang C. Idiopathic Pulmonary Fibrosis Registry China study (PORTRAY): protocol for a prospective, multicentre registry study. BMJ Open. 2020 Nov 11;10(11):e036809. doi: 10.1136/bmjopen-2020-036809.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
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 Idiopathic Pulmonary Fibrosis, run by Dai Huaping 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 4 inclusion and 0 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 11 Sep 2018. 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?
Demographic and clinical characteristic of newly diagnosed Chinese IPF patients (time frame: up to 5 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 NCT03666234, 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 11 Sep 2018.