NCT03666234

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

5 years

First QC Date

June 20, 2018

Last Update Submit

September 10, 2018

Conditions

Keywords

Idiopathic Pulmonary FibrosisEpidemiologyNature History

Outcome Measures

Primary Outcomes (1)

  • Demographic and clinical characteristic of newly diagnosed Chinese IPF patients

    Data analyses will be mainly descriptive.

    up to 5 years

Secondary Outcomes (4)

  • Mortality in Chinese patients with IPF

    up to 5 years

  • Cause of death in Chinese patients with IPF

    up to 5 years

  • Progression-free survival in Chinese patients with IPF

    up to 5 years

  • Description of the acute exacerbations in Chinese patients with IPF

    up to 5 years

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chinese newly diagnosed IPF patients

You may qualify if:

  • 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

You may not qualify if:

  • Lung transplantation expected within the next 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huaping Dai

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (2)

  • Yang X, Wang H, Liu A, Ni Y, Wang J, Han Y, Xie B, Geng J, Ren Y, Zhang R, Liu M, Dai H. Evaluation of respiratory muscle dysfunction in patients with idiopathic pulmonary fibrosis: a prospective observational study with magnetic resonance imaging. BMC Pulm Med. 2025 Mar 14;25(1):118. doi: 10.1186/s12890-025-03572-6.

  • 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.

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director of Center for Respiratory Diseases

Study Record Dates

First Submitted

June 20, 2018

First Posted

September 11, 2018

Study Start

July 1, 2018

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations