Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT01205412
Status:
COMPLETED
Last Update Posted:
2012-11-22
First Post:
2010-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Endocervical samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-21', 'studyFirstSubmitDate': '2010-09-16', 'studyFirstSubmitQcDate': '2010-09-17', 'lastUpdatePostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.', 'timeFrame': 'Average time frame: 12 months'}], 'secondaryOutcomes': [{'measure': 'Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up.', 'timeFrame': 'Average time frame: 12 months'}, {'measure': 'Behavioural risk factors', 'timeFrame': 'During visit 1 (day 0)'}, {'measure': 'Awareness of HPV in relation to transmission and cause of cervical cancer', 'timeFrame': 'Average time frame: 12 months'}]}, 'conditionsModule': {'conditions': ['Human Papillomavirus Infection']}, 'referencesModule': {'references': [{'pmid': '25466757', 'type': 'DERIVED', 'citation': 'Moosa K, Alsayyad AS, Quint W, Gopala K, DeAntonio R. An epidemiological study assessing the prevalence of human papillomavirus types in women in the Kingdom of Bahrain. BMC Cancer. 2014 Dec 3;14:905. doi: 10.1186/1471-2407-14-905.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women ≥ 20 years of age attending routine cervical screening and among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women ≥ 20 years of age, attending out-patient health services for routine cervical screening and women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women ≥ 20 years of age attending a clinic for routine cervical screening OR\n* Women ≥ 16 years of age presenting for post-natal check-ups\n* Women providing a cervical sample\n* Written informed consent or oral-witnessed thumb printed informed consent obtained from the subject\n\nExclusion Criteria:\n\n* Referral for abnormal cervical sample at the current visit\n* Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed (Note: Enrolment can be delayed until this condition is resolved)\n* Pregnant women\n* History of hysterectomy\n* Known diagnosis of immunosuppression, or patient on immunosuppressives\n* Having received one or more doses of human papillomavirus vaccine prior to participating in the study'}, 'identificationModule': {'nctId': 'NCT01205412', 'briefTitle': 'An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain', 'orgStudyIdInfo': {'id': '112710'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Assessed Cohort', 'description': 'Subjects attending out-patient health services for routine cervical screening or presenting for post-natal check up', 'interventionNames': ['Procedure: Endocervical samples']}], 'interventions': [{'name': 'Endocervical samples', 'type': 'PROCEDURE', 'description': 'Endocervical samples collection during routine gynaecological examinations', 'armGroupLabels': ['Assessed Cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manama', 'country': 'Bahrain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.22787, 'lon': 50.58565}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}