Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.

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.

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Key information

Conditions

Interstitial Lung Disease Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Immune System Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Observational Study of Clinical Features and Outcome of Interstitial Lung Disease With Anti-neutrophil Cytoplasmic Antibody in Chinese Patients.

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2020
First posted: Jun 2, 2020
Registry last updated: May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed