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Idiopathic Pulmonary Fibrosis Registry China Study (PORTRAY)

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ClinicalTrials.gov Identifier: NCT03666234
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Dai Huaping, China-Japan Friendship Hospital

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
Idiopathic Pulmonary Fibrosis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. Demographic and clinical characteristic of newly diagnosed Chinese IPF patients [ Time Frame: up to 5 years ]
    Data analyses will be mainly descriptive.


Secondary Outcome Measures :
  1. Mortality in Chinese patients with IPF [ Time Frame: up to 5 years ]
    Mortality will be showed as percentage.

  2. 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.


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

    Patients 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.


  4. Description of the acute exacerbations in Chinese patients with IPF [ Time Frame: up to 5 years ]

    Acute 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.




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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chinese newly diagnosed IPF patients
Criteria

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.

Information from the National Library of Medicine

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


Locations
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China, Beijing
Huaping Dai Recruiting
Beijing, Beijing, China, 100029
Contact: Huaping Dai    0086-13901293597    daihuaping@sina.com   
Sponsors and Collaborators
Dai Huaping

Additional Information:

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Responsible Party: Dai Huaping, Deputy Director of Center for Respiratory Diseases, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT03666234     History of Changes
Other Study ID Numbers: ChinaJapanFH002
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dai Huaping, China-Japan Friendship Hospital:
Idiopathic Pulmonary Fibrosis
Epidemiology
Nature History
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial