Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-01 @ 9:00 AM
Study NCT ID:
NCT06530069
Status:
RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Risk Factors of Otomycosis: A Case-Control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059249', 'term': 'Otomycosis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-07-27', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Odds Ratio', 'timeFrame': '1month', 'description': 'The ratio of exposed to non-exposed individuals in the case group divided by the ratio of exposed to non-exposed individuals in the control group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Otomycosis', 'predisposing factor'], 'conditions': ['Otomycosis']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to explore the risk factors of fungal otitis externa in the fungal otitis externa patients The main question it aims to answer is:\n\nWhat behaviors lead to the occurrence of fungal otitis externa? Participants will complete a detailed questionnaire survey. If there is a comparison group: Researchers will compare the healthy group and the disease group to see if there are any differences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Our institution is a tertiary first-class comprehensive hospital. Both the disease group and the control group are seen and screened at our facility', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms in the case group include tinnitus, ear fullness or blockage, itching, ear pain, discharge, and hearing loss. Physical examination reveals the presence of hyphae, scabs, secretions, masses, pus, red skin, erosion, swelling, or granulation in the ear canal. Laboratory fungal cultures must be positive. The control group does not have the aforementioned ear symptoms and has not sought medical attention for ear-related symptoms.\n\nExclusion Criteria:\n\n* Patients with otitis media, tympanic membrane perforation, or post-radiotherapy.'}, 'identificationModule': {'nctId': 'NCT06530069', 'briefTitle': 'Exploring the Risk Factors of Otomycosis: A Case-Control Study', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Hospital Xiamen University'}, 'officialTitle': 'Exploring the Risk Factors of Otomycosis: A Case-Control Study', 'orgStudyIdInfo': {'id': 'xmzsyyky-2024-078'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case Group', 'description': 'this group consists of patients who have been diagnosed with otomycosis.Observational exposures: Ear cleaning, swimming, wearing earphones, diabetes, immunosuppression, antibiotic ear drops, narrowing of the external auditory canal, etc.', 'interventionNames': ['Other: exposures']}, {'label': 'Control Group', 'description': 'This group includes healthy individuals who have not been diagnosed with otomycosis during medical examinations.Observational exposures: Ear cleaning, swimming, wearing earphones, diabetes, immunosuppression, antibiotic ear drops, narrowing of the external auditory canal, etc.', 'interventionNames': ['Other: exposures']}], 'interventions': [{'name': 'exposures', 'type': 'OTHER', 'description': 'exposures: Ear cleaning, swimming, wearing earphones, diabetes, immunosuppression, antibiotic ear drops, narrowing of the external auditory canal, etc.', 'armGroupLabels': ['Case Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunsheng Ye', 'role': 'CONTACT', 'email': '578881502@qq.com'}], 'facility': 'Zhongshan Hospital of Xiamen university', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'centralContacts': [{'name': 'Chunsheng Ye', 'role': 'CONTACT', 'email': '578881502@qq.com', 'phone': '+8613400661815'}], 'overallOfficials': [{'name': 'Chunsheng Ye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Hospital Xiamen University'}]}, 'ipdSharingStatementModule': {'url': 'http://www.medresman.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The data will be available within six months after the completion of the study and will remain accessible for at least ten years.', 'ipdSharing': 'YES', 'accessCriteria': 'The data will be open to peer-reviewed researchers. Researchers requesting access to the data must submit a research proposal and pass our review process. All data requestors must also adhere to a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Hospital Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}