Interstitial Lung Disease
Conditions
Keywords
progressive pulmonary fibrosis
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.
Interventions
None listed
Sponsors
Qianfoshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish the correlation between Age (years) and progression to PPF | Up to 12 months | — |
| 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 6 min walk test distance (meters) 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) |
| 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 ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) 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 Gender (the proportion of female and the proportion of male) and progression to PPF | Up to 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of PPF | Up to 36 months | Prevalence of PPF in patients with fibrosing ILD. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Establish the correlation between Age (years) and mortality of PPF | Up to 36 months | — |
| Establish the correlation between Biomarkers and mortality of PPF | Up to 36 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 6 min walk test distance (meters) and mortality of PPF | Up to 36 months | — |
| Establish the correlation between Pulmonary function and mortality of PPF | Up to 36 months | Pulmonary function: forced vital capacity (FVC, L) and diffusion capacity for carbon monoxide of the lung (DLCO, mmol/min/kPa) |
| Establish the correlation between Artery blood gas and mortality of PPF | Up to 36 months | Artery blood gas: PaCO2 (mmHg) and PaO2 (mmHg) |
| Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and mortality of PPF | Up to 36 months | — |
| Establish the correlation between Body mass index (BMI, kg/m2) and mortality of PPF | Up to 36 months | — |
| Establish the correlation between Gender (the proportion of female and the proportion of male) and mortality of PPF | Up to 36 months | — |
Countries
China
Contacts
Primary Contactzhi guo, Doctor
Outcome results
None listed