Clinical trial NCT05895409: A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis
Official title: A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Keywords: progressive pulmonary fibrosis
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the first affiliated Hospital of Shandong first Medical University,Jinan Central Hospital,Jinan people's Hospital,The fourth people's Hospital of Jinan and PLA 960 Hospital.

Brief summary: 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.


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

Primary outcomes:
measure: Establish the correlation between Age (years) and progression to PPF
timeFrame: Up to 12 months
measure: Establish the correlation between Gender (the proportion of female and the proportion of male) and progression to PPF
timeFrame: Up to 12 months
measure: Establish the correlation between Body mass index (BMI, kg/m2) and progression to PPF
timeFrame: Up to 12 months
measure: Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and progression to PPF
timeFrame: Up to 12 months
measure: Establish the correlation between Artery blood gas and progression to PPF
timeFrame: Up to 12 months
measure: Establish the correlation between Pulmonary function and progression to PPF
timeFrame: Up to 12 months
measure: Establish the correlation between 6 min walk test distance (meters) and progression to PPF
timeFrame: Up to 12 months
measure: Establish the correlation between Biomarkers and progression to PPF
timeFrame: Up to 12 months
Secondary outcomes:
measure: Prevalence of PPF
timeFrame: Up to 36 months
Other outcomes:
measure: Establish the correlation between Age (years) and mortality of PPF
timeFrame: Up to 36 months
measure: Establish the correlation between Gender (the proportion of female and the proportion of male) and mortality of PPF
timeFrame: Up to 36 months
measure: Establish the correlation between Body mass index (BMI, kg/m2) and mortality of PPF
timeFrame: Up to 36 months
measure: Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and mortality of PPF
timeFrame: Up to 36 months
measure: Establish the correlation between Artery blood gas and mortality of PPF
timeFrame: Up to 36 months
measure: Establish the correlation between Pulmonary function and mortality of PPF
timeFrame: Up to 36 months
measure: Establish the correlation between 6 min walk test distance (meters) and mortality of PPF
timeFrame: Up to 36 months
measure: Establish the correlation between Biomarkers and mortality of PPF
timeFrame: Up to 36 months
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
References: