Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.

NCT ID: NCT04413149

Last Updated: 2024-05-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-01

Study Completion Date

2020-04-01

Brief Summary

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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

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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

Conditions

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Interstitial Lung Disease Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juhong Shi, M.D

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40442650 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PUMCH-ANCA-positive ILD

Identifier Type: -

Identifier Source: org_study_id

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