ABPAABPA-MLNCT07714863
ML-Based ABPA Recurrence Prediction and Clinical Utility
An observational study of ABPA and Allergic Bronchopulmonary Aspergillosis, run by Qianfoshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ABPA, Allergic Bronchopulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis (ABPA)
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
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
13706380314, qiqianqlh@163.com
About this study
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
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.
Read more
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
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (12)
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.
Measured: 1 year
Total serum IgE
Total serum IgE
Measured: 1 year
FEV1 (% predicted)
FEV1 (% predicted)
Measured: 1 year
Changes in chest CT features including scores for bronchiectasis severity
Changes in chest CT features including scores for bronchiectasis severity
Measured: 1 year
Aspergillus-specific IgE
Aspergillus-specific IgE
Measured: 1 year
Aspergillus-specific IgG
Aspergillus-specific IgG
Measured: 1 year
forced vital capacity (FVC)
forced vital capacity (FVC)
Measured: 1 year
FEV1/FVC ratio
FEV1/FVC ratio
Measured: 1 year
diffusing capacity for carbon monoxide (DLCO)
diffusing capacity for carbon monoxide (DLCO)
Measured: 1 year
extent of bronchiectasis of chest CT
extent of bronchiectasis of chest CT
Measured: 1 year
mucus plugging on chest CT
mucus plugging on chest CT
Measured: 1 year
high-attenuation (HAM) on chest CT
high-attenuation (HAM) on chest CT
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jan 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ABPAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714863
- Sponsor's protocol ID
- ABPA-006
- Acronym
- ABPA-ML
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07714863
- Acronym / sponsor ID
- ABPA-ML / ABPA-006
- Conditions
- ABPA, Allergic Bronchopulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis (ABPA), Acute Exacerbation, Machine Learning
- Keywords
- ABPA, Acute exacerbation, Machine Learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
12 secondary outcomes
Time to first acute exacerbation
Time frame: 1 year
Total serum IgE
Time frame: 1 year
FEV1 (% predicted)
Time frame: 1 year
Changes in chest CT features including scores for bronchiectasis severity
Time frame: 1 year
Aspergillus-specific IgE
Time frame: 1 year
Aspergillus-specific IgG
Time frame: 1 year
forced vital capacity (FVC)
Time frame: 1 year
FEV1/FVC ratio
Time frame: 1 year
diffusing capacity for carbon monoxide (DLCO)
Time frame: 1 year
extent of bronchiectasis of chest CT
Time frame: 1 year
mucus plugging on chest CT
Time frame: 1 year
high-attenuation (HAM) on chest CT
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for ABPA
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Real-World Effectiveness of Tezepelumab in Allergic Bronchopulmonary Aspergillosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ABPA and Allergic Bronchopulmonary Aspergillosis, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Qi (+86 13706380314, qiqianqlh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of ABPA exacerbation within one year of enrollment. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.