Idiopathic Pulmonary Fibrosis Registry China Study

Idiopathic Pulmonary Fibrosis Clinical Trial

— PORTRAY  

Official title:

Idiopathic Pulmonary Fibrosis Registry China Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03666234
• Other study ID #: ChinaJapanFH002
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2018
• Source: China-Japan Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
China	Huaping Dai	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dai Huaping

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic and clinical characteristic of newly diagnosed Chinese IPF patients	Data analyses will be mainly descriptive.	up to 5 years
Secondary	Mortality in Chinese patients with IPF	Mortality will be showed as percentage.	up to 5 years
Secondary	Cause of death in Chinese patients with IPF	Cause 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.	up to 5 years
Secondary	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.	up to 5 years
Secondary	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.	up to 5 years