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NCT Number: NCT05895409

A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis

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.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

Location status: Recruiting

Location contact

zhi guo, Doctor

CONTACT

[email protected]

+8613853120761

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Establish the correlation between Age (years) and progression to PPF

    Time frame: Up to 12 months

  2. Establish the correlation between Gender (the proportion of female and the proportion of male) and progression to PPF

    Time frame: Up to 12 months

  3. Establish the correlation between Body mass index (BMI, kg/m2) and progression to PPF

    Time frame: Up to 12 months

  4. Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and progression to PPF

    Time frame: Up to 12 months

  5. Establish the correlation between Artery blood gas and progression to PPF

    Time frame: Up to 12 months

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

  6. Establish the correlation between Pulmonary function and progression to PPF

    Time frame: Up to 12 months

    Pulmonary function: forced vital capacity (FVC, L) and diffusion capacity for carbon monoxide of the lung (DLCO, mmol/min/kPa)

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

    Time frame: Up to 12 months

  8. Establish the correlation between Biomarkers and progression to PPF

    Time frame: 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)

Secondary outcomes

  1. Prevalence of PPF

    Time frame: Up to 36 months

    Prevalence of PPF in patients with fibrosing ILD.

Other outcomes

  1. Establish the correlation between Age (years) and mortality of PPF

    Time frame: Up to 36 months

  2. Establish the correlation between Gender (the proportion of female and the proportion of male) and mortality of PPF

    Time frame: Up to 36 months

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

    Time frame: Up to 36 months

  4. Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and mortality of PPF

    Time frame: Up to 36 months

  5. Establish the correlation between Artery blood gas and mortality of PPF

    Time frame: Up to 36 months

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

  6. Establish the correlation between Pulmonary function and mortality of PPF

    Time frame: Up to 36 months

    Pulmonary function: forced vital capacity (FVC, L) and diffusion capacity for carbon monoxide of the lung (DLCO, mmol/min/kPa)

  7. Establish the correlation between 6 min walk test distance (meters) and mortality of PPF

    Time frame: Up to 36 months

  8. Establish the correlation between Biomarkers and mortality of PPF

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

zhi guo, Doctor

CONTACT

[email protected]

+8613853120761

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Jun 8, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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