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Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction

Multi-Omics Data-Derived Inflammatory Phenotype for ABPA Recurrence Risk Prediction: A Multicenter Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07611838
Enrollment
300
Registered
2026-05-28
Start date
2021-01-01
Completion date
2028-12-31
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Bronchopulmonary Aspergillosis (ABPA), Machine Learning, Multicenter Study, Multi-omics, Relapse

Keywords

Allergic Bronchopulmonary Aspergillosis, Relapse, Machine Learning, Multicenter Study, Multi-omics

Brief 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.

Detailed description

This project aims to develop an inflammatory phenotype-based risk prediction model for recurrence of allergic bronchopulmonary aspergillosis (ABPA) to enable stratified patient management. The study integrates multidimensional data sources, including radiomics, mycobiomics, inflammatory biomarkers, pulmonary function parameters, and routine clinical records. Deep machine learning algorithms are employed to extract and select key features from these multi-omics and clinical datasets, define inflammatory phenotypes, and subsequently construct a recurrence risk prediction model. Based on the risk stratification derived from the model, low-risk individuals will receive regular follow-up, whereas high-risk individuals will undergo intensified intervention and management. This approach is expected to optimize individualized treatment strategies for ABPA patients, reduce recurrence rates, and improve clinical outcomes.

Interventions

None listed

Sponsors

Qianfoshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrent disease occurs in patients during the remission period.1 yearObserve 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.

Countries

China

Contacts

CONTACTQian Qi
qiqianqlh@163.com+86 13706380314
STUDY_DIRECTORQian Qi

Shandong First Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026