A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis

Recruiting

• Conditions: Interstitial Lung Disease

• Registration Number: NCT05895409
• Lead Sponsor: Qianfoshan 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-08
• Study Start: 2023-07-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2026-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 610

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish the correlation between Gender (the proportion of female and the proportion of male) and progression to PPF	Up to 12 months
Establish the correlation between Artery blood gas and progression to PPF	Up to 12 months	Artery blood gas: PaCO2 (mmHg) and PaO2 (mmHg)
Establish the correlation between Biomarkers and progression to PPF	Up to 12 months	Biomarkers:CCL18(pg/mL),KL-6(pg/mL),CA125(pg/mL),MMP-7(pg/mL),SP-D(pg/mL) and IL-6(pg/mL)
Establish the correlation between Age (years) and progression to PPF	Up to 12 months
Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and progression to PPF	Up to 12 months
Establish the correlation between 6 min walk test distance (meters) and progression to PPF	Up to 12 months
Establish the correlation between Body mass index (BMI, kg/m2) and progression to PPF	Up to 12 months
Establish the correlation between Pulmonary function and progression to PPF	Up to 12 months	Pulmonary function: forced vital capacity (FVC, L) and diffusion capacity for carbon monoxide of the lung (DLCO, mmol/min/kPa)

Secondary Outcome Measures

Name	Time	Method
Prevalence of PPF	Up to 36 months	Prevalence of PPF in patients with fibrosing ILD.

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China