A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis

NCT05895409 | Recruiting

• 1 other identifier: YXLL-KY-2023(029)
• Study Type: observational
• Target: 610
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Keywords

progressive pulmonary fibrosis

Outcome Measures

Primary Outcomes (8)

• Establish the correlation between Age (years) 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

• Establish the correlation between Body mass index (BMI, kg/m2) 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 Artery blood gas and progression to PPF

  Artery blood gas: PaCO2 (mmHg) and PaO2 (mmHg)

  Up to 12 months

• 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

• Establish the correlation between 6 min walk test distance (meters) and progression to PPF

  Up to 12 months

• 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 Outcomes (1)

• Prevalence of PPF

  Up to 36 months

Other Outcomes (8)

• Establish the correlation between Age (years) 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

• Establish the correlation between Body mass index (BMI, kg/m2) and mortality of PPF

  Up to 36 months

Study Arms (1)

PF

Patients with interstitial lung disease (ILD) of known or unknown etiology other than IPF who has radiological evidence of pulmonary fibrosis(PF).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years old
• Agree and sign the informed consent form
• Interstitial lung disease patients with imaging features of pulmonary fibrosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

zhi guo, Doctor

CONTACT

+8613853120761; guozhi770217@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 8, 2023
• Study Start: July 27, 2023
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)