Allergic Bronchopulmonary Aspergillosis (ABPA)NCT07611838
Multi-Omics Inflammatory Phenotype for ABPA Recurrence Risk Prediction
An observational study of Allergic Bronchopulmonary Aspergillosis (ABPA) and Machine Learning, run by Qianfoshan Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Allergic Bronchopulmonary Aspergillosis (ABPA), Machine Learning, Multi-omics
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Female and Male patients aged 18-80 years
- diagnosis of Allergic Bronchopulmonary Aspergillosis ABPA accroding to the 2024 ISHAM Working Group Diagnostic Criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- 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
Qian Qi, Dr., +86 13706380314, qiqianqlh@163.com
About this study
Official title: 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.
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.
- Conditions
- Allergic Bronchopulmonary Aspergillosis (ABPA), Machine Learning, Multi-omics, Multicenter Study, Relapse
- Keywords
- Allergic Bronchopulmonary Aspergillosis, Relapse, Machine Learning, Multicenter Study, Multi-omics
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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：
- 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jan 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Bronchopulmonary Aspergillosis (ABPA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
- Investigators
- Qian Qi, Study director, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611838
- Sponsor's protocol ID
- ABPA-004
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omics Data-Derived Inflammatory Phenotype for ABPA Recurrence Risk Prediction: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07611838
- Acronym / sponsor ID
- ABPA-004
- Conditions
- Allergic Bronchopulmonary Aspergillosis (ABPA), Machine Learning, Multi-omics, Multicenter Study, Relapse
- Keywords
- Allergic Bronchopulmonary Aspergillosis, Relapse, Machine Learning, Multicenter Study, Multi-omics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Female and Male patients aged 18-80 years
- diagnosis of Allergic Bronchopulmonary Aspergillosis ABPA accroding to the 2024 ISHAM Working Group Diagnostic Criteria
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrent disease occurs in patients during the remission period.
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qian Qi study director
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Bronchopulmonary Aspergillosis (ABPA) and Machine Learning, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Qi (+86 13706380314, qiqianqlh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent disease occurs in patients during the remission period. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.