ML-Based ABPA Recurrence Prediction and Clinical Utility | NCT07714863

NCT07714863

Overview

NCT ID: NCT07714863
Lead Sponsor: Qianfoshan HospitalOTHER
Official Title: Machine Learning-Based Prediction of Recurrence Risk in Allergic Bronchopulmonary Aspergillosis and Its Clinical Decision-Making Value: A Multicenter Study With External Validation
Brief Summary: This multicenter bidirectional cohort study aims to develop and externally validate a machine learning model for predicting the risk of acute exacerbation within 1 year in patients with allergic bronchopulmonary aspergillosis (ABPA) during the stable phase, and further to evaluate the model's practical value in risk stratification and clinical decision-making.

All patients diagnosed with ABPA according to the ISHAM 2024 criteria will be assigned to either the acute exacerbation group or the non-exacerbation group based on whether they experience an acute exacerbation within 1 year. Enrolled participants will be randomly divided into a training set and an internal validation set. During the feature selection phase, univariate analysis, collinearity diagnostics, feature importance ranking derived from nine machine learning algorithms, and expert consensus are comprehensively applied, ultimately leading to the development of 12 independent machine learning models.

Model performance is assessed using the receiver operating characteristic (ROC) curve and its area under the curve (AUC), sensitivity, specificity, F1-score, calibration curve, and decision curve analysis. In addition, external validation further enhances the credibility of the model. To improve clinical interpretability, the SHAP method is employed to quantify the contribution of each feature, and an interactive nomogram is constructed to facilitate clinical application.

All participants will be followed up for 12 months, during which regular clinical and laboratory evaluations will be performed.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Jan 1, 2021Actual
Primary Completion Date: Dec 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Aged between 18 and 80 years old.

Consistent with the diagnostic consensus criteria for ABPA proposed by the ISHAM-ABPA Working Group.

Patients in stable phase of ABPA: newly diagnosed treatment-naive patients or those with prior ABPA exacerbation who achieved at least 50% improvement in symptoms assessed by Likert scale or visual analogue scale (VAS) following initial therapy, accompanied by marked radiological improvement (≥50% reduction in pulmonary opacities) or a minimum 20% decline in serum total IgE level.

Exclusion Criteria:

Concurrent malignant tumors or severe organ dysfunction involving the heart, brain, kidney and other vital organs.

Complicated with severe underlying diseases, including active pulmonary tuberculosis, lung cancer, chronic heart failure (NYHA class Ⅳ), chronic kidney disease stage 5 (CKD 5), decompensated liver cirrhosis, etc.

Immunocompromised status, such as human immunodeficiency virus (HIV) infection, long-term oral administration of glucocorticoids or immunosuppressive agents.

Pregnant or breastfeeding women.

Patients with missing core clinical data or incomplete medical records.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 200Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Qian QiContact
qiqianqlh@163.com+86 13706380314

Similar Studies

Participant Group/Arms

ABPA Exacerbation Group

All subjects met the 2024 ISHAM consensus diagnostic criteria for allergic bronchopulmonary aspergillosis. An ABPA exacerbation was defined based on the official ISHAM 2024 criteria: patients with established ABPA presenting with sustained clinical worsening for over 14 days or radiological deterioration, accompanied by a ≥50% elevation in serum total IgE compared to the stable baseline level, after ruling out alternative causes of disease flare. Those who developed an ABPA exacerbation satisfying the above definition within one year of study entry were assigned to the ABPA exacerbation group.

Non-exacerbation Group

All subjects fulfilled the 2024 ISHAM consensus diagnostic criteria for allergic bronchopulmonary aspergillosis, and those without any ABPA flare meeting the above exacerbation definition within one year after study entry were assigned to the non-exacerbation group.