Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction

NCT07611838 | Recruiting

• 1 other identifier: ABPA-004
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Allergic Bronchopulmonary Aspergillosis; Relapse; Machine Learning; Multicenter Study; Multi-omics

Outcome Measures

Primary Outcomes (1)

• Recurrent disease occurs in patients during the remission period.

  Observe whether disease recurrence occurs in ABPA patients who have reached stable phase after treatment. Stable Phase： 1. Symptomatic improvement by at least 50% (on a Likert or visual analog scale) after eight weeks; and, 2. 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 1. Sustained (\>14 days) clinical worsening, or 2. Radiological worsening, and 3. Increase in serum total IgE by ≥50% from the last recorded IgE value during clinical stability, along with 4. Exclusion of other causes of worsening.

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

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

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma, sputum, bronchoalveolar lavage fluid, stool, urine.

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary; Recurrence

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qian Qi

  Shandong First Medical University

  STUDY DIRECTOR

Central Study Contacts

Qian Qi

CONTACT

+86 13706380314; qiqianqlh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)