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PORTRAY: Idiopathic Pulmonary Fibrosis Registry China Study

Sponsor
Dai Huaping (Other)
Overall Status
Recruiting
CT.gov ID
NCT03666234
Collaborator
(none)
800
Enrollment
1
Location
60
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Idiopathic Pulmonary Fibrosis Registry China Study
    Actual Study Start Date :
    Jul 1, 2018
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Demographic and clinical characteristic of newly diagnosed Chinese IPF patients [up to 5 years]

      Data analyses will be mainly descriptive.

    Secondary Outcome Measures

    1. Mortality in Chinese patients with IPF [up to 5 years]

      Mortality will be showed as percentage.

    2. Cause of death in Chinese patients with IPF [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.

    3. Progression-free survival in Chinese patients with IPF [up to 5 years]

      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.

    4. Description of the acute exacerbations in Chinese patients with IPF [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Huaping Dai Beijing Beijing China 100029

    Sponsors and Collaborators

    • Dai Huaping

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dai Huaping, Deputy Director of Center for Respiratory Diseases, China-Japan Friendship Hospital
    ClinicalTrials.gov Identifier:
    NCT03666234
    Other Study ID Numbers:
    • ChinaJapanFH002
    First Posted:
    Sep 11, 2018
    Last Update Posted:
    Sep 11, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dai Huaping, Deputy Director of Center for Respiratory Diseases, China-Japan Friendship Hospital
    Idiopathic Pulmonary Fibrosis
    Epidemiology
    Nature History
    Additional relevant MeSH terms:
    Pulmonary Fibrosis
    Idiopathic Pulmonary Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Sep 11, 2018