Skip to content

Idiopathic Pulmonary Fibrosis Registry China Study

Idiopathic Pulmonary Fibrosis Registry China Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03666234
Acronym
PORTRAY
Enrollment
800
Registered
2018-09-11
Start date
2018-07-01
Completion date
2023-06-30
Last updated
2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis, Epidemiology, Nature History

Brief 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, prognosis, comorbidities and complications of IPF patients in China, the current treatment pattern, burden of illness, and quality of life of Chinese IPF patients.

Interventions

None listed

Sponsors

Dai Huaping
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Inclusion in any interventional clinical trials * Lung transplantation expected within the next 6 months.

Design outcomes

Primary

MeasureTime frameDescription
Demographic and clinical characteristic of newly diagnosed Chinese IPF patientsup to 5 yearsData analyses will be mainly descriptive.

Secondary

MeasureTime frameDescription
Mortality in Chinese patients with IPFup to 5 yearsMortality will be showed as percentage.
Cause of death in Chinese patients with IPFup to 5 yearsCause of death: a. 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.
Progression-free survival in Chinese patients with IPFup to 5 yearsPatients without the following events: 1. Death 2. Lung transplantation 3. Acute exacerbation 4. Require long-term oxygen therapy 5. Hospitalization for respiratory reasons The unit of progression-free survival is day.
Description of the acute exacerbations in Chinese patients with IPFup to 5 yearsAcute exacerbation of IPF (AE-IPF) 1. Previous diagnosis or simultaneous diagnosis of IPF; 2. Symptoms generally manifest as dyspnea with acute exacerbations or progression within 1 month; 3. Chest CT shows new bilateral glass ground or solid shadows on the basis of usual interstitial pneumonia (UIP); 4. Exacerbations cannot be completely explained by heart failure or increased volume load. The incidence of the acute exacerbation will be showed as percentage.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026