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Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction

28 maggio 2026 aggiornato da: Qian Qi, Qianfoshan Hospital

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

300

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Qian Qi
Numero di telefono: +86 13706380314
Email: qiqianqlh@163.com

Luoghi di studio

Cina
- Shandong
  - Jinan, Shandong, Cina, 250014
    - Reclutamento
    - 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
    - Contatto:
      
      Qian Qi, Dr.
      
      Numero di telefono: +86 13706380314
      
      Email: qiqianqlh@163.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Metodo di campionamento

Campione di probabilità

Popolazione di studio

1）Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA 2)These patients who were clearly diagnosed with ABPA are currently in stable phase

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
ABPA recurrence group and No ABPA recurrence group Patients with stable ABPA who visited multicenter hospitals between January 2021 and January 2025 were enrolled and followed up for one year. Based on the definition of ABPA relapse, they were categorized into a relapse group and a non-relapse group. Key features from medical records, inflammatory markers, fungal omics, radiomics, and pulmonary function tests were selected for model development.

Gruppo / Coorte

ABPA recurrence group and No ABPA recurrence group

Patients with stable ABPA who visited multicenter hospitals between January 2021 and January 2025 were enrolled and followed up for one year. Based on the definition of ABPA relapse, they were categorized into a relapse group and a non-relapse group. Key features from medical records, inflammatory markers, fungal omics, radiomics, and pulmonary function tests were selected for model development.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Recurrent disease occurs in patients during the remission period. Lasso di tempo: 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.	1 year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Qianfoshan Hospital

Investigatori

Direttore dello studio: Qian Qi, Shandong First medical university

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2021

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

21 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità