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A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05895409
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Qianfoshan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease
Arms & Interventions

Arms

: PF

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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Jinan, Shandong, China

Status

Recruiting

Address

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000

Site Contact

zhi guo, Doctor

[email protected]

+8613853120761