Clinical trial NCT04413149: Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.
Official title: Observational Study of Clinical Features and Outcome of Interstitial Lung Disease With Anti-neutrophil Cytoplasmic Antibody in Chinese Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Keywords: Interstitial Lung Disease
Anti-Neutrophil Cytoplasmic Antibody
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interstitial lung disease patients with anti-neutrophil cytoplasmic antibody.

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

Eligibility criteria: 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

Primary outcomes:
measure: Death From All Causes
timeFrame: From baseline until the date of death from all cause, up to 5 years
measure: Number of Patients Who Underwent Lung Transplantation
timeFrame: From baseline until the date of transplantation, up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Juhong Shi, M.D
role: STUDY_CHAIR
References: