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Recruiting NCT07611838

Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction

Observational Allergic Bronchopulmonary Aspergillosis (ABPA) Machine Learning Multi-omics Multicenter Study

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Allergic Bronchopulmonary Aspergillosis (ABPA), Machine Learning, Multi-omics, Multicenter Study. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Recurrent disease occurs in patients during the remission period. [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical Univers — Jinan

Identifiers

NCT: NCT07611838 · ABPA-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗