Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT06228469
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytolytic Vaginosis Multicentre Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D019522', 'term': 'Vaginal Discharge'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-01-18', 'studyFirstSubmitQcDate': '2024-01-18', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize cytolytic vaginosis', 'timeFrame': '1 year', 'description': 'Describe the risk factors, symptoms, signs and treatment outcomes of cytoytic vaginosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaginitis', 'Lactobacillus', 'Wet mount', 'Vaginal microbiome', 'Fragmented epithelial cells', 'Vaginal discharge'], 'conditions': ['Cytolytic Vaginosis']}, 'descriptionModule': {'briefSummary': 'The goal of this registry is to learn more about cytolytic vaginosis, a little known and controversial condition. The main questions the registry aims to answer are:\n\n* What are risk factors of cytolytic vaginosis?\n* Are there defining symptoms of cytolytic vaginosis?\n* What features on wet mount should be used to diagnosis cytolytic vaginosis?\n* Are baking soda vaginal irrigations an effective treatment for cytolytic vaginosis?\n* Do characteristics of cytolytic vaginosis vary between sites/countries?', 'detailedDescription': 'Cytolytic vaginosis is a largely unknown, debated, and equivocal vaginal condition. It is unclear whether cytolytic vaginosis is a variant of normal vaginal microbiome or should be considered a vaginal dysbiosis condition, similar to bacterial vaginosis. This multicentre registry will enroll women that have signs/symptoms consistent with cytolytic vaginosis to better characterize it.\n\nWomen at participating sites diagnosed with cytolytic vaginosis and that provide consent will be consecutively enrolled in the registry. The registry will capture data on risk factors, symptoms, test results (eg, wet mount) and treatment outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women attending an outpatient clinic with vaginitis symptoms', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vaginitis symptoms\n* Predominately lactobacilli or/and elongated lactobacilli on wet mount\n* Cytolysis on wet mount\n\nExclusion Criteria:\n\n* Unable to consent or decline consent\n* Pregnant\n* Positive for yeast (culture or PCR)'}, 'identificationModule': {'nctId': 'NCT06228469', 'briefTitle': 'Cytolytic Vaginosis Multicentre Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Cytolytic Vaginosis Multicentre Registry', 'orgStudyIdInfo': {'id': 'Pro00122929'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women diagnosed with cytolytic vaginosis', 'description': 'Women presenting to an outpatient clinic with vaginitis symptoms and diagnosed with cytolytic vaginosis.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Niterói', 'state': 'Rio de Janeiro', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Isabel do Val, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Susana Aidé, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline Oliveira, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universidade Federal Fluminense-UFF', 'geoPoint': {'lat': -22.88333, 'lon': -43.10361}}, {'city': 'Multiple Locations', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Roni Kraut, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Angela Vinturache, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tatiana Dragan, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Outpatient clinics'}, {'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Pedro Vieira-Baptista, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Hospitalar de São João', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Roni Kraut, MD', 'role': 'CONTACT', 'email': 'rkraut@ualberta.ca', 'phone': '780.492.8306'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}