A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis

Interstitial Lung Disease Clinical Trial

Official title:

A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895409
• Other study ID #: YXLL-KY-2023(029)
• Status: Recruiting
• Start date: July 27, 2023
• Est. completion date: June 1, 2028

Study information

• Verified date: November 2023
• Source: Qianfoshan Hospital
• Contact: zhi guo, Doctor
• Phone: +8613853120761
• Email: guozhi770217[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 610
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Establish the correlation between Age (years) and mortality of PPF		Up to 36 months
Other	Establish the correlation between Gender (the proportion of female and the proportion of male) and mortality of PPF		Up to 36 months
Other	Establish the correlation between Body mass index (BMI, kg/m2) and mortality of PPF		Up to 36 months
Other	Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and mortality of PPF		Up to 36 months
Other	Establish the correlation between Artery blood gas and mortality of PPF	Artery blood gas: PaCO2 (mmHg) and PaO2 (mmHg)	Up to 36 months
Other	Establish the correlation between Pulmonary function and mortality of PPF	Pulmonary function: forced vital capacity (FVC, L) and diffusion capacity for carbon monoxide of the lung (DLCO, mmol/min/kPa)	Up to 36 months
Other	Establish the correlation between 6 min walk test distance (meters) and mortality of PPF		Up to 36 months
Other	Establish the correlation between Biomarkers and mortality of PPF	Biomarkers:CCL18(pg/mL),KL-6(pg/mL),CA125(pg/mL),MMP-7(pg/mL),SP-D(pg/mL) and IL-6(pg/mL)	Up to 36 months
Primary	Establish the correlation between Age (years) and progression to PPF		Up to 12 months
Primary	Establish the correlation between Gender (the proportion of female and the proportion of male) and progression to PPF		Up to 12 months
Primary	Establish the correlation between Body mass index (BMI, kg/m2) and progression to PPF		Up to 12 months
Primary	Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and progression to PPF		Up to 12 months
Primary	Establish the correlation between Artery blood gas and progression to PPF	Artery blood gas: PaCO2 (mmHg) and PaO2 (mmHg)	Up to 12 months
Primary	Establish the correlation between Pulmonary function and progression to PPF	Pulmonary function: forced vital capacity (FVC, L) and diffusion capacity for carbon monoxide of the lung (DLCO, mmol/min/kPa)	Up to 12 months
Primary	Establish the correlation between 6 min walk test distance (meters) and progression to PPF		Up to 12 months
Primary	Establish the correlation between Biomarkers and progression to PPF	Biomarkers:CCL18(pg/mL),KL-6(pg/mL),CA125(pg/mL),MMP-7(pg/mL),SP-D(pg/mL) and IL-6(pg/mL)	Up to 12 months
Secondary	Prevalence of PPF	Prevalence of PPF in patients with fibrosing ILD.	Up to 36 months