Idiopathic Pulmonary Fibrosis Registry China Study (PORTRAY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03666234|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
|Condition or disease|
|Idiopathic Pulmonary Fibrosis|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Idiopathic Pulmonary Fibrosis Registry China Study|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
- Demographic and clinical characteristic of newly diagnosed Chinese IPF patients [ Time Frame: up to 5 years ]Data analyses will be mainly descriptive.
- Mortality in Chinese patients with IPF [ Time Frame: up to 5 years ]Mortality will be showed as percentage.
- Cause of death in Chinese patients with IPF [ Time Frame: up to 5 years ]
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.
- Progression-free survival in Chinese patients with IPF [ Time Frame: up to 5 years ]
Patients without the following events:
- Lung transplantation
- Acute exacerbation
- Require long-term oxygen therapy
- Hospitalization for respiratory reasons
The unit of progression-free survival is day.
- Description of the acute exacerbations in Chinese patients with IPF [ Time Frame: up to 5 years ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666234
|Beijing, Beijing, China, 100029|
|Contact: Huaping Dai 0086-13901293597 firstname.lastname@example.org|