Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction

28. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Qian Qi
Telefonnummer: +86 13706380314
E-post: qiqianqlh@163.com

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, Jinan, Shandong 250014
    - Ta kontakt med:
      
      Qian Qi, Dr.
      
      Telefonnummer: +86 13706380314
      
      E-post: qiqianqlh@163.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Gruppe / Kohort

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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Recurrent disease occurs in patients during the remission period. Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Qianfoshan Hospital

Etterforskere

Studieleder: Qian Qi, Shandong First medical university

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2021

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene