Interstitial Lung DiseaseNCT05895409
A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis
An observational study of Interstitial Lung Disease, run by Qianfoshan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 610 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2023to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18-80 years old
- Agree and sign the informed consent form
- Interstitial lung disease patients with imaging features of pulmonary fibrosis
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
zhi guo, Doctor, +8613853120761, guozhi770217@163.com
About this study
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
Read more
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
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PF | Patients with interstitial lung disease (ILD) of known or unknown etiology other than IPF who has radiological evidence of pulmonary fibrosis(PF). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the correlation between Age (years) and progression to PPF
Measured: Up to 12 months
Establish the correlation between Gender (the proportion of female and the proportion of male) and progression to PPF
Measured: Up to 12 months
Establish the correlation between Body mass index (BMI, kg/m2) and progression to PPF
Measured: Up to 12 months
Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and progression to PPF
Measured: Up to 12 months
Establish the correlation between Artery blood gas and progression to PPF
Artery blood gas: PaCO2 (mmHg) and PaO2 (mmHg)
Measured: 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)
Measured: Up to 12 months
Establish the correlation between 6 min walk test distance (meters) and progression to PPF
Measured: 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)
Measured: Up to 12 months
Secondary outcomes (1)
Prevalence of PPF
Prevalence of PPF in patients with fibrosing ILD.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start27 Jul 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi Guo, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895409
- Sponsor's protocol ID
- YXLL-KY-2023(029)
- Status last verified
- Nov 2023
- First submitted
- 9 May 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05895409
- Acronym / sponsor ID
- YXLL-KY-2023(029)
- Conditions
- Interstitial Lung Disease
- Keywords
- progressive pulmonary fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF | – | –Patients with interstitial lung disease (ILD) of known or unknown etiology other than IPF who has radiological evidence of pulmonary fibrosis(PF). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18-80 years old
- Agree and sign the informed consent form
- Interstitial lung disease patients with imaging features of pulmonary fibrosis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish the correlation between Age (years) and progression to PPF
Time frame: Up to 12 months
Establish the correlation between Gender (the proportion of female and the proportion of male) and progression to PPF
Time frame: Up to 12 months
Establish the correlation between Body mass index (BMI, kg/m2) and progression to PPF
Time frame: Up to 12 months
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
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)
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)
Establish the correlation between 6 min walk test distance (meters) and progression to PPF
Time frame: Up to 12 months
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)
1 secondary outcome
Prevalence of PPF
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhi guo, Doctor (+8613853120761, guozhi770217@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the correlation between Age (years) and progression to PPF (time frame: Up to 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.