NCT04413149

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 17, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

5 years

First QC Date

May 25, 2020

Results QC Date

July 14, 2020

Last Update Submit

May 10, 2024

Conditions

Keywords

Interstitial Lung DiseaseAnti-Neutrophil Cytoplasmic AntibodyAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Outcome Measures

Primary Outcomes (2)

  • Death From All Causes

    Death from all causes Retrieved from medical records.

    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.

    From baseline until the date of transplantation, up to 5 years

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Interstitial lung disease patients with anti-neutrophil cytoplasmic antibody.

You may qualify if:

  • 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

You may not qualify if:

  • Connective tissue disease associated ILD
  • ILD induced by drug, environment, or occupational exposure
  • Hypersensitivity pneumonitis and sarcoidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Lung Diseases, InterstitialAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesSystemic VasculitisVasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Selection bias is possible due to its retrospective nature.

Results Point of Contact

Title
Dr. Shi Juhong
Organization
Peking Union Medical College Hospital

Study Officials

  • Juhong Shi, M.D

    Peking Union Medical College Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2020

First Posted

June 2, 2020

Study Start

April 1, 2014

Primary Completion

April 1, 2019

Study Completion

April 1, 2020

Last Updated

May 17, 2024

Results First Posted

May 17, 2024

Record last verified: 2024-05

Locations