Eosinophil SubtypeNCT06944418
The Study of Differences in Eosinophil Function and Subsets in Patients With Eosinophilic Pulmonary Diseases
An observational study of Eosinophil Subtype and Eosinophilic Pulmonary Diseases, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The study subjects of this research are patients with eosinophil-associated pulmonary diseases, including eosinophilic granulomatosis with polyangiitis, idiopathic hypereosinophilic syndrome, idiopathic acute eosinophilic pneumonia, idiopathic chronic eosinophilic pneumonia, and primary simple pulmonary eosinophilia. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophil Subtype, Eosinophilic Pulmonary Diseases
- What is being tested?
- observation
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 2027
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients diagnosed with EPD who meet the inclusion criteria above.
Who may be able to join
- For Healthy Volunteers: healthy volunteers matching the age and gender of the study subjects
- For EPD: ① Persistent eosinophil count increase>1500 per cubic millimeter for more than 6 months. ② Lack of evidence of a secondary cause of eosinophilia is required. ③ Signs and symptoms of end-organ damage presumed to be secondary to eosinophilia
Who cannot join
- Patients with concurrent definitive pulmonary infections, malignancies, or other parenchymal lung diseases;
- Patients who are unable or unwilling to cooperate with the collection of clinical information (e.g., due to mental disorders, memory impairments, etc.);
- Patients who are unable to provide informed consent.
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Juhong Shi, M.D, +8613701178492, shijh@pumch.cn
About this study
Official title: The Study of Differences in Eosinophil Function and Subsets in Patients With Eosinophilic Pulmonary Diseases Based on Flow Cytometry Analysis
The study subjects of this research are patients with eosinophil-associated pulmonary diseases, including eosinophilic granulomatosis with polyangiitis, idiopathic hypereosinophilic syndrome, idiopathic acute eosinophilic pneumonia, idiopathic chronic eosinophilic pneumonia, and primary simple pulmonary eosinophilia. The aim is to detect eosinophil subtypes in peripheral blood based on surface protein expression, to understand the differences in eosinophil subtypes among patients with different diseases, to elucidate the significance of different eosinophil subtypes, and ultimately to provide a theoretical basis for the selection of treatment directions for patients.
- Being tested
- observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eosinophil Subtypes in Serum
Proportion of Eosinophil Subtypes in Serum Before and After Treatment in Patients
Measured: From January 1, 2024 to January 1, 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophil SubtypeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juhong Shi, M.D, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944418
- Sponsor's protocol ID
- PUMCH-EPD
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 25 Apr 2025
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Differences in Eosinophil Function and Subsets in Patients With Eosinophilic Pulmonary Diseases Based on Flow Cytometry Analysis
- ClinicalTrials.gov ID
- NCT06944418
- Acronym / sponsor ID
- PUMCH-EPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Apr 2025 (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.
The study subjects of this research are patients with eosinophil-associated pulmonary diseases, including eosinophilic granulomatosis with polyangiitis, idiopathic hypereosinophilic syndrome, idiopathic acute eosinophilic pneumonia, idiopathic chronic eosinophilic pneumonia, and primary simple pulmonary eosinophilia. The aim is to detect eosinophil subtypes in peripheral blood based on surface protein expression, to understand the differences in eosinophil subtypes among patients with different diseases, to elucidate the significance of different eosinophil subtypes, and ultimately to provide a theoretical basis for the selection of treatment directions for patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients diagnosed with EPD who meet the inclusion criteria above.
Key inclusion criteria (2 listed)
- For Healthy Volunteers: healthy volunteers matching the age and gender of the study subjects
- For EPD: ① Persistent eosinophil count increase>1500 per cubic millimeter for more than 6 months. ② Lack of evidence of a secondary cause of eosinophilia is required. ③ Signs and symptoms of end-organ damage presumed to be secondary to eosinophilia
Key exclusion criteria (3 listed)
- Patients with concurrent definitive pulmonary infections, malignancies, or other parenchymal lung diseases;
- Patients who are unable or unwilling to cooperate with the collection of clinical information (e.g., due to mental disorders, memory impairments, etc.);
- Patients who are unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationobservation | Other | – |
Primary outcome
Proportion of Eosinophil Subtypes in Serum
Time frame: From January 1, 2024 to January 1, 2027
Proportion of Eosinophil Subtypes in Serum Before and After Treatment in Patients
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 25 Apr 2025.
- Individual participant dataSharing planned: No
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.
Juhong Shi, M.D study chair
Peking Union Medical College Hospital
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 Eosinophil Subtype and Eosinophilic Pulmonary Diseases, run by Peking Union Medical College 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 3 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 25 Apr 2025. 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 Juhong Shi, M.D (+8613701178492, shijh@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Eosinophil Subtypes in Serum (time frame: From January 1, 2024 to January 1, 2027). 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 25 Apr 2025.