Idiopathic Pulmonary Fibrosis Registry China Study (PORTRAY)

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 Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Huaping Dai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chinese newly diagnosed IPF patients

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and clinical characteristic of newly diagnosed Chinese IPF patients	Data analyses will be mainly descriptive.	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality in Chinese patients with IPF	Mortality will be showed as percentage.	up to 5 years
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
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
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

Collaborators and Investigators

• Sponsor: Dai Huaping

Publications and helpful links

General Publications

• Xie 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Epidemiology; Idiopathic Pulmonary Fibrosis; Nature History
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: ChinaJapanFH002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No