An observational study in ABPA, Allergic Bronchopulmonary Aspergillosis and Allergic Bronchopulmonary Aspergillosis (ABPA), sponsored by Qianfoshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Qianfoshan Hospital · Observational
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.
42 studies on the registry are indexed under Aspergillosis, Allergic Bronchopulmonary; 13 are open to participants now.
This study's planned enrollment of 200 is above the median of 73 across 14 observational studies indexed under Aspergillosis, Allergic Bronchopulmonary.
Browse Aspergillosis, Allergic Bronchopulmonary studies →Qianfoshan Hospital is the lead sponsor of 144 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: 1 year
Time to first acute exacerbation
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.
Time frame: 1 year
Total serum IgE
Total serum IgE
Time frame: 1 year
FEV1 (% predicted)
FEV1 (% predicted)
Time frame: 1 year
Changes in chest CT features including scores for bronchiectasis severity
Changes in chest CT features including scores for bronchiectasis severity
Time frame: 1 year
Aspergillus-specific IgE
Aspergillus-specific IgE
Time frame: 1 year
Aspergillus-specific IgG
Aspergillus-specific IgG
Time frame: 1 year
forced vital capacity (FVC)
forced vital capacity (FVC)
Time frame: 1 year
FEV1/FVC ratio
FEV1/FVC ratio
Time frame: 1 year
diffusing capacity for carbon monoxide (DLCO)
diffusing capacity for carbon monoxide (DLCO)
Time frame: 1 year
extent of bronchiectasis of chest CT
extent of bronchiectasis of chest CT
Time frame: 1 year
mucus plugging on chest CT
mucus plugging on chest CT
Time frame: 1 year
high-attenuation (HAM) on chest CT
high-attenuation (HAM) on chest CT
Time frame: 1 year
Plan to share: No
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Started Jan 2021 (actual). Primary completion is estimated for Dec 2028, 95 months after the start.
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Aspergillosis, Allergic Bronchopulmonary →