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