ML-Based ABPA Recurrence Prediction and Clinical Utility

NCT07714863 | Recruiting

• 1 other identifier: ABPA-006
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

ABPA; Allergic Bronchopulmonary Aspergillosis; Allergic Bronchopulmonary Aspergillosis (ABPA); Acute Exacerbation; Machine Learning

Keywords

ABPA; Acute exacerbation; Machine Learning

Outcome Measures

Primary Outcomes (1)

• The occurrence of ABPA exacerbation within one year of enrollment.

  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.

  1 year

Secondary Outcomes (12)

• Time to first acute exacerbation

  1 year

• Total serum IgE

  1 year

• FEV1 (% predicted)

  1 year

• Changes in chest CT features including scores for bronchiectasis severity

  1 year

• Aspergillus-specific IgE

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study enrolled adult patients aged ≥ 18 years with a confirmed diagnosis of allergic bronchopulmonary aspergillosis (ABPA) who met the 2024 ISHAM diagnostic criteria. Study subjects consisted of retrospectively identified cases extracted from the electronic medical records of participating hospitals, as well as prospectively recruited patients enrolled during the research period. Eligible patients were required to achieve disease stability following initial treatment and possess complete datasets covering clinical manifestations, chest imaging findings, laboratory test results, treatment regimens, and records of ABPA exacerbation events. All participants were stratified into an ABPA exacerbation group and a non-exacerbation group. Patients who failed to attain stable disease after initial treatment, lacked core clinical data, or were lost to follow-up were excluded from the analysis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

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, China

RECRUITING

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Qian Qi

CONTACT

+86 13706380314; qiqianqlh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 20, 2026
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)