ClinicalTrials.gg
RecruitingNCT07611838Updated Jun 1, 2026

Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction

An observational study in Allergic Bronchopulmonary Aspergillosis (ABPA), Machine Learning and Multi-omics, sponsored by Qianfoshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Qianfoshan Hospital · Observational

From the registry’s dates

  • Started Jan 2021; still recruiting 5 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Allergic Bronchopulmonary Aspergillosis
  • Relapse
  • Machine Learning
  • Multicenter Study
  • Multi-omics
03

In context

Aspergillosis, Allergic Bronchopulmonary

42 studies on the registry are indexed under Aspergillosis, Allergic Bronchopulmonary; 13 are open to participants now.

This study's planned enrollment of 300 is above the median of 73 across 14 observational studies indexed under Aspergillosis, Allergic Bronchopulmonary.

Browse Aspergillosis, Allergic Bronchopulmonary studies →

Lead sponsor

Qianfoshan Hospital is the lead sponsor of 144 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ( class Ⅳ), chronic kidney disease (CKD stage 5), decompensated cirrhosis, etc.
  • Patients with status, such as infection, long-term use of oral or immunosuppressive agents.
  • Pregnant or lactating women.
  • Patients with missing key data or incomplete medical records.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2021 (actual). Primary completion is estimated for Dec 2028, 95 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2026
First posted
May 28, 2026
StartActual
Jan 1, 2021
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Jun 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07611838
Responsible party
Qian Qi (Prof, Qianfoshan Hospital) — Principal investigator
First posted
May 28, 2026
Start date
Jan 1, 2021
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jun 1, 2026

Study contacts

Qian Qi
Contact
qiqianqlh@163.com
+86 13706380314
Qian Qi
study director · Shandong First Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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