Interstitial Lung DiseaseNCT04413149
Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.
An observational study of Interstitial Lung Disease and Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the clinical features and long-term outcome of anti-neutrophil cytoplasmic antibody (ANCA)-positive interstitial lung disease (ILD) and assess the difference between microscopic polyangiitis (MPA) associated ILD and isolated ANCA-positive idiopathic interstitial pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Interstitial Lung Disease, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2014to 1 Apr 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Interstitial lung disease patients with anti-neutrophil cytoplasmic antibody.
Who may be able to join
- Males and females
- Aged from 18 to 85 years with informed consent
- Have a diagnosis of ILD based on clinical symptoms and radiologic features, with or without histopathologic results
- Have available ANCA testing results during the first visit and follow-up period
Who cannot join
- Connective tissue disease associated ILD
- ILD induced by drug, environment, or occupational exposure
- Hypersensitivity pneumonitis and sarcoidosis
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Observational Study of Clinical Features and Outcome of Interstitial Lung Disease With Anti-neutrophil Cytoplasmic Antibody in Chinese Patients.
The purpose of this study is to investigate the clinical features and long-term outcome of anti-neutrophil cytoplasmic antibody (ANCA)-positive interstitial lung disease (ILD) and assess the difference between microscopic polyangiitis (MPA) associated ILD and isolated ANCA-positive idiopathic interstitial pneumonia.
Read the detailed description
ILD patients with serum ANCA-positivity were enrolled in this study.
- Baseline data collection:
- Demographics information (age, gender)
- Clinical course
- Clinical symptoms and signs (cough, dyspnea, fever, fatigue, crackling, clubbing fingers, mechanics hand)
- Laboratory findings (blood and urine routine, liver and renal function tests, erythrocyte sedimentation rate, C reactive protein)
- Serologic tests (ANA , Rheumatoid factor , Anti-cyclic citrullinated peptide (CCP), Anti-dsDNA, Anti-Ro (SS-A), Anti-La (SS-B), Anti-Smith, Anti-Scl-70, Anti-Jo-1)
- Systemic manifestation if diagnosed as systemic vasculitis
- Pulmonary function tests (ventilation and diffusion capacity test)
- Chest high-resolution computed tomography (HRCT)
- Treatment: treatment will be given according to the experience of each pulmonologist.
- Follow-up:
- Patients were followed up at least once a year and basic laboratory tests, serologic autoantibodies, pulmonary function test and chest HRCT were evaluated routinely
- Follow-up end point was April 2019.
- Outcome
- Keywords
- Interstitial Lung Disease, Anti-Neutrophil Cytoplasmic Antibody, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Medical subject headings
- Lung Diseases, Interstitial, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Death From All Causes
Death from all causes Retrieved from medical records.
Measured: From baseline until the date of death from all cause, up to 5 years
Number of Patients Who Underwent Lung Transplantation
Number of patients who underwent lung transplantation Retrieved from medical records.
Measured: From baseline until the date of transplantation, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Apr 2014
- Primary completion1 Apr 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juhong Shi, M.D, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413149
- Sponsor's protocol ID
- PUMCH-ANCA-positive ILD
- Status last verified
- May 2024
- First submitted
- 25 May 2020
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun X, Zhu W, Zhou C, Xue P, Li Z, Zhang W, Zhao J, Zhang T, Peng M, Shi J, Wang C. Clinical significance of anti-neutrophil cytoplasmic antibody in idiopathic interstitial pneumonia: a retrospective observational study. BMC Pulm Med. 2025 May 29;25(1):271. doi: 10.1186/s12890-025-03736-4.
PubMed 40442650
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Clinical Features and Outcome of Interstitial Lung Disease With Anti-neutrophil Cytoplasmic Antibody in Chinese Patients.
- ClinicalTrials.gov ID
- NCT04413149
- Acronym / sponsor ID
- PUMCH-ANCA-positive ILD
- Keywords
- Interstitial Lung Disease, Anti-Neutrophil Cytoplasmic Antibody, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Posted 17 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the clinical features and long-term outcome of anti-neutrophil cytoplasmic antibody (ANCA)-positive interstitial lung disease (ILD) and assess the difference between microscopic polyangiitis (MPA) associated ILD and isolated ANCA-positive idiopathic interstitial pneumonia.
Detailed description
ILD patients with serum ANCA-positivity were enrolled in this study.
- Baseline data collection:
- Demographics information (age, gender)
- Clinical course
- Clinical symptoms and signs (cough, dyspnea, fever, fatigue, crackling, clubbing fingers, mechanics hand)
- Laboratory findings (blood and urine routine, liver and renal function tests, erythrocyte sedimentation rate, C reactive protein)
- Serologic tests (ANA , Rheumatoid factor , Anti-cyclic citrullinated peptide (CCP), Anti-dsDNA, Anti-Ro (SS-A), Anti-La (SS-B), Anti-Smith, Anti-Scl-70, Anti-Jo-1)
- Systemic manifestation if diagnosed as systemic vasculitis
- Pulmonary function tests (ventilation and diffusion capacity test)
- Chest high-resolution computed tomography (HRCT)
- Treatment: treatment will be given according to the experience of each pulmonologist.
- Follow-up:
- Patients were followed up at least once a year and basic laboratory tests, serologic autoantibodies, pulmonary function test and chest HRCT were evaluated routinely
- Follow-up end point was April 2019.
- Outcome
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Interstitial lung disease patients with anti-neutrophil cytoplasmic antibody.
Key inclusion criteria (4 listed)
- Males and females
- Aged from 18 to 85 years with informed consent
- Have a diagnosis of ILD based on clinical symptoms and radiologic features, with or without histopathologic results
- Have available ANCA testing results during the first visit and follow-up period
Key exclusion criteria (3 listed)
- Connective tissue disease associated ILD
- ILD induced by drug, environment, or occupational exposure
- Hypersensitivity pneumonitis and sarcoidosis
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
Death From All Causes
Time frame: From baseline until the date of death from all cause, up to 5 years
Death from all causes Retrieved from medical records.
Number of Patients Who Underwent Lung Transplantation
Time frame: From baseline until the date of transplantation, up to 5 years
Number of patients who underwent lung transplantation Retrieved from medical records.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40442650Sun X, Zhu W, Zhou C, Xue P, Li Z, Zhang W, Zhao J, Zhang T, Peng M, Shi J, Wang C. Clinical significance of anti-neutrophil cytoplasmic antibody in idiopathic interstitial pneumonia: a retrospective observational study. BMC Pulm Med. 2025 May 29;25(1):271. doi: 10.1186/s12890-025-03736-4.
Related trials for Interstitial Lung Disease
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
Radiation Pneumonitis
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
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. This study is not recruiting at the moment.
Juhong Shi, M.D study chair
Peking Union Medical College Hospital
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 and Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, run by Peking Union Medical College 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 17 May 2024. 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?
Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death From All Causes (time frame: From baseline until the date of death from all cause, up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04413149, which also lists 1 linked publication.
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 17 May 2024.