Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06944418
Status:
RECRUITING
Last Update Posted:
2025-04-25
First Post:
2025-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Study of Differences in Eosinophil Function and Subsets in Patients With Eosinophilic Pulmonary Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2025-03-30', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Eosinophil Subtypes in Serum', 'timeFrame': 'From January 1, 2024 to January 1, 2027', 'description': 'Proportion of Eosinophil Subtypes in Serum Before and After Treatment in Patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eosinophil Subtype', 'Eosinophilic Pulmonary Diseases']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients diagnosed with EPD who meet the inclusion criteria above.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For Healthy Volunteers: healthy volunteers matching the age and gender of the study subjects\n* 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\n\nExclusion Criteria:\n\n* Patients with concurrent definitive pulmonary infections, malignancies, or other parenchymal lung diseases;\n* Patients who are unable or unwilling to cooperate with the collection of clinical information (e.g., due to mental disorders, memory impairments, etc.);\n* Patients who are unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06944418', 'briefTitle': 'The Study of Differences in Eosinophil Function and Subsets in Patients With Eosinophilic Pulmonary Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Study of Differences in Eosinophil Function and Subsets in Patients With Eosinophilic Pulmonary Diseases Based on Flow Cytometry Analysis', 'orgStudyIdInfo': {'id': 'PUMCH-EPD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observation', 'type': 'OTHER', 'description': 'observation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juhong Shi, M.D', 'role': 'CONTACT', 'email': 'shijh@pumch.cn', 'phone': '+8613701178492'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Juhong Shi, M.D', 'role': 'CONTACT', 'email': 'shijh@pumch.cn', 'phone': '+8613701178492'}], 'overallOfficials': [{'name': 'Juhong Shi, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}