Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.

Completed

• Conditions: Interstitial Lung Disease; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

• Registration Number: NCT04413149
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

ILD patients with serum ANCA-positivity were enrolled in this study.

1. Baseline data collection:

1. Demographics information (age, gender)

2. Clinical course

3. Clinical symptoms and signs (cough, dyspnea, fever, fatigue, crackling, clubbing fingers, mechanics hand)

4. Laboratory findings (blood and urine routine, liver and renal function tests, erythrocyte sedimentation rate, C reactive protein)

5. 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)

6. Systemic manifestation if diagnosed as systemic vasculitis

7. Pulmonary function tests (ventilation and diffusion capacity test)

8. Chest high-resolution computed tomography (HRCT)

2. Treatment: treatment will be given according to the experience of each pulmonologist.

3. Follow-up:

1. Patients were followed up at least once a year and basic laboratory tests, serologic autoantibodies, pulmonary function test and chest HRCT were evaluated routinely

2. Follow-up end point was April 2019.

4. Outcome

Study Timeline

• Study Start: 2014-04-01
• Primary Completion: 2019-04-01
• Study Completion: 2020-04-01
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-02
• Results First Submitted: 2020-07-14
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Results First Posted: 2024-05-17
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death From All Causes	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	From baseline until the date of transplantation, up to 5 years	Number of patients who underwent lung transplantation Retrieved from medical records.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China