Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-02 @ 1:25 AM
Study NCT ID:
NCT07040332
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathogenesis and Inflammatory Phenotype of Allergic Bronchopulmonary Aspergillosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001229', 'term': 'Aspergillosis, Allergic Bronchopulmonary'}], 'ancestors': [{'id': 'D055732', 'term': 'Pulmonary Aspergillosis'}, {'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total serum IgE', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Aspergillus-specific IgE', 'timeFrame': 'Up to 12 months'}, {'measure': 'Aspergillus-specific IgG', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Bronchopulmonary Aspergillosis (ABPA)']}, 'descriptionModule': {'briefSummary': 'This study aims to reveal the immune and inflammatory regulatory molecular mechanisms related to the progression of allergic bronchopulmonary aspergillosis (ABPA), and to build a precision typing based on inflammation and identify the biomarkers of typing, and to explore the clinical outcomes of different inflammatory phenotypes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients with allergic bronchopulmonary aspergillosis and fungal-sensitized asthma who were treated in several hospitals were included as the study objects, and the relatively normal ones who had no bronchial asthma and no fungal sensitization were matched by gender and age as the control group, and then the cohorts of patients with allergic bronchopulmonary aspergillosis, fungal-sensitized asthma and the control group were established.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets the diagnostic criteria for allergic bronchopulmonary aspergillosis.\n* Meets the diagnostic criteria for fungal-sensitized asthma.\n\nExclusion Criteria:\n\n* Human immunodeficiency virus infection.\n* Malignant tumor.\n* Blood system disease.\n* autoimmune system disease.\n* History of pulmonary tuberculosis.\n* Patients with a history of smoking or still smoking.\n* Invasive pulmonary fungal disease.\n* Contraindications electronic bronchoscopy'}, 'identificationModule': {'nctId': 'NCT07040332', 'briefTitle': 'Pathogenesis and Inflammatory Phenotype of Allergic Bronchopulmonary Aspergillosis', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Pathogenesis and Inflammatory Phenotype of Allergic Bronchopulmonary Aspergillosis', 'orgStudyIdInfo': {'id': 'QFS-2025-074'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'allergic bronchopulmonary aspergillosis'}, {'label': 'fungal-sensitized asthma'}, {'label': 'control group'}], 'interventions': [{'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['allergic bronchopulmonary aspergillosis', 'control group', 'fungal-sensitized asthma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Qi, Dr.', 'role': 'CONTACT', 'email': 'qiqianqlh@163.com', 'phone': '+86 13706380314'}], 'facility': 'Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Qian Qi, Prof.', 'role': 'CONTACT', 'email': 'qiqianqlh@163.com', 'phone': '+86 13706380314'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Pulmonary Hospital, Tongji University School of Medicine', 'class': 'UNKNOWN'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': "Guizhou Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Qian Qi', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}