Allergic Bronchopulmonary AspergillosisNCT06645210
Multicenter Registration Study on Allergic Bronchopulmonary Aspergillosis
An observational study of Allergic Bronchopulmonary Aspergillosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
To understand the current diagnosis and treatment status of ABPA patients, observe their clinical characteristics, prognosis, and treatment outcomes, and identify the relevant factors for poor prognosis in patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Allergic Bronchopulmonary Aspergillosis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 31 Jan 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed with ABPA
Who may be able to join
- Meeting the diagnosis of ABPA according to the ABPA diagnostic criteria specified by the ISHAM-ABPA working group in 2024
Who cannot join
- ABPA patients who are not first diagnosed in the center
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
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
15801601229, jiaqi@bjmu.edu.cn
About this study
Official title: A Multicenter Retrospective Cohort Study on Allergic Bronchopulmonary Aspergillosis
To understand the current diagnosis and treatment status of ABPA patients, observe their clinical characteristics, prognosis, and treatment outcomes, and identify the relevant factors for poor prognosis in patients.
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Keywords
- cohort study
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical classification and treatment response criteria for ABPA
- Acute ABPA
- Response
- Remission
- Treatment-dependent ABPA
- Advanced ABPA
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 posted16 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Bronchopulmonary AspergillosisStudies 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Guangxi Medical University, Guangzhou Institute of Respiratory Disease, Tongji Hospital, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital with Nanjing Medical University, Qianfoshan Hospital, The First Affiliated Hospital of Shanxi Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, West China Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Xiangya Hospital of Central South University, Peking Union Medical College Hospital, Ruijin Hospital
- Responsible party
- Principal investigator, Sun Yongchang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645210
- Sponsor's protocol ID
- M2024692
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Retrospective Cohort Study on Allergic Bronchopulmonary Aspergillosis
- ClinicalTrials.gov ID
- NCT06645210
- Acronym / sponsor ID
- M2024692
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Keywords
- cohort study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Guangxi Medical University, Guangzhou Institute of Respiratory Disease, Tongji Hospital, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital with Nanjing Medical University, Qianfoshan Hospital, The First Affiliated Hospital of Shanxi Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, West China Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Xiangya Hospital of Central South University, Peking Union Medical College Hospital, Ruijin Hospital
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 16 Oct 2024 (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 understand the current diagnosis and treatment status of ABPA patients, observe their clinical characteristics, prognosis, and treatment outcomes, and identify the relevant factors for poor prognosis in patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with ABPA
Key inclusion criteria (1 listed)
- Meeting the diagnosis of ABPA according to the ABPA diagnostic criteria specified by the ISHAM-ABPA working group in 2024
Key exclusion criteria (1 listed)
- ABPA patients who are not first diagnosed in the center
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
Clinical classification and treatment response criteria for ABPA
Time frame: 1 year
1. Acute ABPA 2. Response 3. Remission 4. Treatment-dependent ABPA 5. Advanced ABPA
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 16 Oct 2024.
- 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.
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, run by Peking University Third 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 16 Oct 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical classification and treatment response criteria for ABPA (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 16 Oct 2024.