A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Interstitial Lung Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Establish the correlation between Age (years) and progression to PPF [Time frame: Up to 12 months]
- Establish the correlation between Gender (the proportion of female and the proportion of male) and progression to PPF [Time frame: Up to 12 months]
- Establish the correlation between Body mass index (BMI, kg/m2) and progression to PPF [Time frame: Up to 12 months]
- Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and progression to PPF [Time frame: Up to 12 months]
- Establish the correlation between Artery blood gas and progression to PPF [Time frame: Up to 12 months]
- Establish the correlation between Pulmonary function and progression to PPF [Time frame: Up to 12 months]
- Establish the correlation between 6 min walk test distance (meters) and progression to PPF [Time frame: Up to 12 months]
- Establish the correlation between Biomarkers and progression to PPF [Time frame: Up to 12 months]
Secondary outcome measures (1)
- Prevalence of PPF [Time frame: Up to 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Shandong First Medical University — Jinan
Identifiers
NCT: NCT05895409 · YXLL-KY-2023(029)