Clinical Trials in China / NCT07611838
Recruiting
Observational
Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction
NCT07611838 · tracked via the Priya Life Science China tracker
Condition(s) studied
Allergic Bronchopulmonary Aspergillosis (ABPA)Machine LearningMulti-omicsMulticenter StudyRelapse
Study summary
To develop and externally validate a machine learning model for predicting the 1-year risk of relapse in patients with stable ABPA, and to further evaluate its value in risk stratification and clinical decision-making.
Eligibility
Inclusion Criteria:
* Female and Male patients aged 18-80 years
* diagnosis of Allergic Bronchopulmonary Aspergillosis ABPA accroding to the 2024 ISHAM Working Group Diagnostic Criteria
Exclusion Criteria:
* Patients with malignant tumors or severe organ dysfunction (e.g., cardiac, cerebral, renal, etc.)
* Patients with severe comorbidities, including active pulmonary tuberculosis, lung cancer, chronic heart failure (NYHA class Ⅳ), chronic kidney disease (CKD stage 5), decompensated cirrhosis, etc.
* Patients with immunosuppressive status, such as HIV infection, long-term use of oral corticosteroids or immunosuppressive agents.
* Pregnant or lactating women.
* Patients with missing key data or incomplete medical records.
Primary outcome measure(s)
- Recurrent disease occurs in patients during the remission period. — 1 year
Observe whether disease recurrence occurs in ABPA patients who have reached stable phase after treatment. Stable Phase： 1. Symptomatic improvement by at least 50% (on a Likert or visual analog scale) after eight weeks; and, 2. Major radiological improvement (\>50% reduction in radiologic opacities) or decline in serum total IgE by at least 20% after eight weeks of treatment. Exacerbation/Recurrence: In a patient with diagnosed ABPA 1. Sustained (\>14 days) clinical worsening, or 2. Radiological worsening, and 3. Increase in serum total IgE by ≥50% from the last recorded IgE value during clinical stability, along with 4. Exclusion of other causes of worsening.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China, Jinan, Shandong 250014 | Jinan | Shandong | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07611838 on ClinicalTrials.gov ↗ ← All trials in China