A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis

NCT ID: NCT05895409

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-27

Study Completion Date

2028-06-01

Brief Summary

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The goal of this observational study is to learn about risk of progressive pulmonary fibrosis (PPF). The main questions it aims to answer are:

* Risk factors of PPF
* Prevalence of PPF
* Mortality of PPF

Patients with interstitial lung disease (ILD) of known or unknown etiology other than IPF who has radiological evidence of pulmonary fibrosis will enroll in this study.

* All participants will have baseline investigations at the first visit having provided informed consent.
* At the first visit, baseline characteristics will be collected including demographics, medical history, smoking history, complications and medication use. 50 mL of blood will be obtained. High resolution computed tomography (HRCT), full lung function tests and a 6 min walk test will be performed.
* Further visits at 6 months and 12 months will include further 50 mL blood sampling. HRCT, full lung function tests and a 6 min walk test will be repeated.

Detailed Description

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Conditions

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Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PF

Patients with interstitial lung disease (ILD) of known or unknown etiology other than IPF who has radiological evidence of pulmonary fibrosis(PF).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18-80 years old
* Agree and sign the informed consent form
* Interstitial lung disease patients with imaging features of pulmonary fibrosis

Exclusion Criteria

* Patients with idiopathic pulmonary fibrosis (IPF)
* Pregnant or lactating women
* mental illness or cognitive impairment
* participating in other clinical studies
* Unable to sign informed consent form
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhi Guo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zhi guo, Doctor

Role: CONTACT

+8613853120761

Facility Contacts

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zhi guo, Doctor

Role: primary

+8613853120761

Other Identifiers

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YXLL-KY-2023(029)

Identifier Type: -

Identifier Source: org_study_id

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