Interstitial Lung Disease Associated

Completed

• Conditions: Interstitial Lung Disease

• Registration Number: NCT06007040
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This single-center, retrospective cohort study was conducted to determine whether ANCA-ILD spectrum share the same clinical manifestations and outcome with CTD feature disease spectrum.

Detailed Description

We retrospectively reviewed patients who had been diagnosed with interstitial pneumonia during outpatient or hospitalization at Peking Union Medical College Hospital (PUMCH) between January 2012 and December 2021.

1. Baseline data collection:

1. Baseline information at the time of initial diagnosis was obtained, and the following items were analyzed: demographic information (age, gender), clinical course, clinical symptoms and signs, laboratory findings \[routine blood, erythrocyte sedimentation rate (ESR), hypersensitivity C-reactive protein (Hs-CRP), rheumatoid factor (RF) and serologic autoantibodies\], pulmonary function tests (PFTs), and chest HRCT scans.

2. MPO-ANCA and PR3-ANCA titers were measured by ELISA.

3. Chest HRCT images were evaluated by at least two pulmonologists and radiologists. The HRCT scans were analyzed for the following characteristics: ground-glass opacities, reticular patterns, honeycombing, traction bronchiectasis.

4. Spirometry was performed according to standardized guidelines. PFTs results were expressed as percentages of the predicted values, thereby correcting for age, gender and bodyweight.

2. Treatment was defined as the use of corticosteroids ≥ 10mg/d, azathioprine, cyclophosphamide, mycophenolate mofetil, methotrexate, or rituximab. Follow-up was up to the time of patient's last visit or time of death, and the outcomes were defined as death from all causes.

3. Outcome

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2023-08
• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Study First Posted: 2023-08-23
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Exclusion Criteria

• 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
All-cause mortality	From baseline until the date of death from all cause, up to 5 years	death from all causes

Trial Locations

Locations (1)

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