NCT06944418

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Jan 2024Jan 2027

Study Start

First participant enrolled

January 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

March 30, 2025

Last Update Submit

April 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of Eosinophil Subtypes in Serum

    Proportion of Eosinophil Subtypes in Serum Before and After Treatment in Patients

    From January 1, 2024 to January 1, 2027

Interventions

observation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients diagnosed with EPD who meet the inclusion criteria above.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Juhong Shi, M.D

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Juhong Shi, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2025

First Posted

April 25, 2025

Study Start

January 1, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations