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ML-Based ABPA Recurrence Prediction and Clinical Utility (ABPA-ML)

14. juli 2026 opdateret af: Qian Qi, Qianfoshan Hospital

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.

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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Shandong
      • Jinan, Shandong, Kina, 250014
        • Rekruttering
        • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
        • Kontakt:

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  1. Aged between 18 and 80 years old.
  2. Consistent with the diagnostic consensus criteria for ABPA proposed by the ISHAM-ABPA Working Group.
  3. 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:

  1. Concurrent malignant tumors or severe organ dysfunction involving the heart, brain, kidney and other vital organs.
  2. 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.
  3. Immunocompromised status, such as human immunodeficiency virus (HIV) infection, long-term oral administration of glucocorticoids or immunosuppressive agents.
  4. Pregnant or breastfeeding women.
  5. Patients with missing core clinical data or incomplete medical records.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The occurrence of ABPA exacerbation within one year of enrollment.
Tidsramme: 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.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to first acute exacerbation
Tidsramme: 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.
1 year
Total serum IgE
Tidsramme: 1 year
Total serum IgE
1 year
FEV1 (% predicted)
Tidsramme: 1 year
FEV1 (% predicted)
1 year
Changes in chest CT features including scores for bronchiectasis severity
Tidsramme: 1 year
Changes in chest CT features including scores for bronchiectasis severity
1 year
Aspergillus-specific IgE
Tidsramme: 1 year
Aspergillus-specific IgE
1 year
Aspergillus-specific IgG
Tidsramme: 1 year
Aspergillus-specific IgG
1 year
forced vital capacity (FVC)
Tidsramme: 1 year
forced vital capacity (FVC)
1 year
FEV1/FVC ratio
Tidsramme: 1 year
FEV1/FVC ratio
1 year
diffusing capacity for carbon monoxide (DLCO)
Tidsramme: 1 year
diffusing capacity for carbon monoxide (DLCO)
1 year
extent of bronchiectasis of chest CT
Tidsramme: 1 year
extent of bronchiectasis of chest CT
1 year
mucus plugging on chest CT
Tidsramme: 1 year
mucus plugging on chest CT
1 year
high-attenuation (HAM) on chest CT
Tidsramme: 1 year
high-attenuation (HAM) on chest CT
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Qianfoshan Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2021

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABPA-006

Plan for individuelle deltagerdata (IPD)

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