Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-23 @ 1:51 PM
Study NCT ID:
NCT02898818
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal and Oral Microbiome Crosstalk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'swab sample from vaginal ja oral smear, including microbes and epithelial cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-09-07', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'microbiome, papa smear', 'timeFrame': '5 years', 'description': 'Differences in microbiome and papa smear'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy', 'Vaginal Discharge']}, 'descriptionModule': {'briefSummary': 'To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear will be studied.', 'detailedDescription': 'To study the vaginal and oral microbiome by swab samples and on selected groups, by papa smear test, to find out the constitution of normal and vaginal microbiome and the cross-talk between oral and vaginal mucosa. To find out about the impact of human papilloma virus on the microbiome and vice versa.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients coming to Turku University Hospital Dermato-Venereology Department for venereal disease tests with or without vaginal discharge. Patients coming to Turku University Hospital Gynaecology Department by remission because of atypical papa smear test result or (controls) for some other reason. Patients coming to family planning clinics in The wellbeing services county of Southwest Finland.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients coming to Turku University Hospital Dermato-Venereology or Gynaecology Departments or to family planning clinics in The wellbeing services county of Southwest Finland for previously mentioned reasons\n\nExclusion Criteria:\n\n* those not meeting the criteria'}, 'identificationModule': {'nctId': 'NCT02898818', 'briefTitle': 'Vaginal and Oral Microbiome Crosstalk', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'EMMI - Emättimen Mikrobiomi - Emättimen ja Suun Limakalvojen Vuorovaikutus', 'orgStudyIdInfo': {'id': 'T146/2016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'symptomless', 'description': 'vaginal and oral swab sample, questionnaire', 'interventionNames': ['Other: vaginal and oral swab sample, questionnaire']}, {'label': 'vaginal discharge', 'description': 'vaginal and oral swab sample, questionnaire', 'interventionNames': ['Other: vaginal and oral swab sample, questionnaire']}, {'label': 'atypical papa smear', 'description': 'vaginal and oral swab sample, questionnaire, papa smear', 'interventionNames': ['Other: vaginal and oral swab sample, questionnaire', 'Other: papa smear']}, {'label': 'no atypical papa smear', 'description': 'vaginal and oral swab sample, questionnaire, papa smear', 'interventionNames': ['Other: vaginal and oral swab sample, questionnaire', 'Other: papa smear']}, {'label': 'lichen planus', 'description': 'vaginal and oral swab sample, questionnaire, papa smear', 'interventionNames': ['Other: vaginal and oral swab sample, questionnaire', 'Other: papa smear']}], 'interventions': [{'name': 'vaginal and oral swab sample, questionnaire', 'type': 'OTHER', 'description': 'vaginal and oral swab sample and questionnaire', 'armGroupLabels': ['atypical papa smear', 'lichen planus', 'no atypical papa smear', 'symptomless', 'vaginal discharge']}, {'name': 'papa smear', 'type': 'OTHER', 'description': 'Papnicolaou Papa Smear test', 'armGroupLabels': ['atypical papa smear', 'lichen planus', 'no atypical papa smear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20540', 'city': 'Turku', 'state': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Niina K Hieta, MD, PhD', 'role': 'CONTACT', 'email': 'niina.hieta@tyks.fi', 'phone': '2-3131620', 'phoneExt': '+358-'}, {'name': 'Katja M Kero, MD, PhD', 'role': 'CONTACT', 'email': 'katja.kero@tyks.fi', 'phone': '2-3130000', 'phoneExt': '+358-'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Niina K Hieta, MD, PhD', 'role': 'CONTACT', 'email': 'niina.hieta@tyks.fi', 'phone': '2-3131620', 'phoneExt': '+358-'}, {'name': 'Katja M Kero, Md, PhD', 'role': 'CONTACT', 'email': 'katja.kero@tyks.fi', 'phone': '2-3130000', 'phoneExt': '+358-'}], 'overallOfficials': [{'name': 'Niina K Hieta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'specialist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Oulu University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}