Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorQianfoshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female and Male patients aged 18-80 years

diagnosis of Allergic Bronchopulmonary Aspergillosis ABPA accroding to the 2024 ISHAM Working Group Diagnostic Criteria

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: ABPA recurrence group and No ABPA recurrence group

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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