Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-25 @ 6:54 PM
Study NCT ID:
NCT05327192
Status:
COMPLETED
Last Update Posted:
2022-08-18
First Post:
2022-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VVC Sampling Study for Analysis Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'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': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Vaginal samples to study bacterial DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate resolution of bacterial DNA sequencing using 16S regions.', 'timeFrame': '1 day'}], 'primaryOutcomes': [{'measure': 'Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture.', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vulvovaginal Candidiasis']}, 'descriptionModule': {'briefSummary': 'This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC.\n\nThe study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.\n\nVaginal samples will be examined under a microscope for yeast forms (hyphae or pseudohyphae) or budding yeast. If the Investigator assesses that the patient has VVC, based on examination and the potassium hydroxide (KOH) test, two vaginal secretion samples will be collected by a vaginal swab. One sample will be cultured to verify the presence of Candida and the other will be used for sequencing analysis of the vaginal microbiome.\n\nSamples from a total of 10 women are planned to be taken.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult women aged 18 years or older\n2. Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:\n\n 1. At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.\n 2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.\n3. Having decisional capacity and providing written informed consent\n4. Signed informed consent and willing and able to comply with all study requirements\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT05327192', 'briefTitle': 'VVC Sampling Study for Analysis Validation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gedea Biotech AB'}, 'officialTitle': 'Collection of Samples From Women Diagnosed With Vulvovaginal Candidiasis for Validation of Vaginal Microbiome Analysis Method', 'orgStudyIdInfo': {'id': 'CL4-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention, only sampling', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Slough', 'country': 'United Kingdom', 'facility': 'Research and Development Department, Berkshire Healthcare NHS Foundation Trust', 'geoPoint': {'lat': 51.50949, 'lon': -0.59541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gedea Biotech AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}