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NCT Number: NCT07714863

ML-Based ABPA Recurrence Prediction and Clinical Utility

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year

    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.

Secondary outcomes

  1. Time to first acute exacerbation

    Time frame: 1 year

    The time from enrollment to the first ABPA exacerbation was recorded. An ABPA exacerbation was defined per the official 2024 ISHAM criteria: patients with established ABPA exhibiting sustained clinical worsening lasting >14 days or radiological deterioration, alongside a ≥50% rise in serum total IgE from their stable baseline, with other causes of clinical deterioration excluded.

  2. Total serum IgE

    Time frame: 1 year

    Total serum IgE

  3. FEV1 (% predicted)

    Time frame: 1 year

    FEV1 (% predicted)

  4. Changes in chest CT features including scores for bronchiectasis severity

    Time frame: 1 year

    Changes in chest CT features including scores for bronchiectasis severity

  5. Aspergillus-specific IgE

    Time frame: 1 year

    Aspergillus-specific IgE

  6. Aspergillus-specific IgG

    Time frame: 1 year

    Aspergillus-specific IgG

  7. forced vital capacity (FVC)

    Time frame: 1 year

    forced vital capacity (FVC)

  8. FEV1/FVC ratio

    Time frame: 1 year

    FEV1/FVC ratio

  9. diffusing capacity for carbon monoxide (DLCO)

    Time frame: 1 year

    diffusing capacity for carbon monoxide (DLCO)

  10. extent of bronchiectasis of chest CT

    Time frame: 1 year

    extent of bronchiectasis of chest CT

  11. mucus plugging on chest CT

    Time frame: 1 year

    mucus plugging on chest CT

  12. high-attenuation (HAM) on chest CT

    Time frame: 1 year

    high-attenuation (HAM) on chest CT

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

Machine Learning-Based Prediction of Recurrence Risk in Allergic Bronchopulmonary Aspergillosis and Its Clinical Decision-Making Value: A Multicenter Study With External Validation

Acronym: ABPA-ML

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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