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NCT Number: NCT07611838

Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction

To develop and externally validate a machine learning model for predicting the 1-year risk of relapse in patients with stable ABPA, and to further evaluate its value in risk stratification and clinical decision-making.

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Key information

Age range

18 year–80 year

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

Jinan, Shandong, 250014, China

Location status: Recruiting

Location contact

Qian Qi, Dr.

CONTACT

[email protected]

+86 13706380314

About this study

This project aims to develop an inflammatory phenotype-based risk prediction model for recurrence of allergic bronchopulmonary aspergillosis (ABPA) to enable stratified patient management. The study integrates multidimensional data sources, including radiomics, mycobiomics, inflammatory biomarkers, pulmonary function parameters, and routine clinical records. Deep machine learning algorithms are employed to extract and select key features from these multi-omics and clinical datasets, define inflammatory phenotypes, and subsequently construct a recurrence risk prediction model. Based on the risk stratification derived from the model, low-risk individuals will receive regular follow-up, whereas high-risk individuals will undergo intensified intervention and management. This approach is expected to optimize individualized treatment strategies for ABPA patients, reduce recurrence rates, and improve clinical outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female and Male patients aged 18-80 years
  • diagnosis of Allergic Bronchopulmonary Aspergillosis ABPA accroding to the 2024 ISHAM Working Group Diagnostic Criteria

Exclusion criteria

  • Patients with malignant tumors or severe organ dysfunction (e.g., cardiac, cerebral, renal, etc.)
  • Patients with severe comorbidities, including active pulmonary tuberculosis, lung cancer, chronic heart failure (NYHA class Ⅳ), chronic kidney disease (CKD stage 5), decompensated cirrhosis, etc.
  • Patients with immunosuppressive status, such as HIV infection, long-term use of oral corticosteroids or immunosuppressive agents.
  • Pregnant or lactating women.
  • Patients with missing key data or incomplete medical records.

Treatment and study plan

Primary outcomes

  1. Recurrent disease occurs in patients during the remission period.

    Time frame: 1 year

    Observe whether disease recurrence occurs in ABPA patients who have reached stable phase after treatment.

    Stable Phase:

    • Symptomatic improvement by at least 50% (on a Likert or visual analog scale) after eight weeks; and,
    • Major radiological improvement (>50% reduction in radiologic opacities) or decline in serum total IgE by at least 20% after eight weeks of treatment.

    Exacerbation/Recurrence: In a patient with diagnosed ABPA

    • Sustained (>14 days) clinical worsening, or
    • Radiological worsening, and
    • Increase in serum total IgE by ≥50% from the last recorded IgE value during clinical stability, along with
    • Exclusion of other causes of worsening.

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

Multi-Omics Data-Derived Inflammatory Phenotype for ABPA Recurrence Risk Prediction: A Multicenter Study

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 28, 2026
Registry last updated
Jun 1, 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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