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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06007040
Other study ID # PUMCH-PCCM-ILD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2012
Est. completion date December 2021

Study information

Verified date August 2023
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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


Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality death from all causes From baseline until the date of death from all cause, up to 5 years
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