Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-05 @ 5:38 PM
Study NCT ID:
NCT02188004
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2014-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D003218', 'term': 'Condylomata Acuminata'}], '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'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Male:Two swabs were used to collect exfoliated skin cells from the coronal sulcus /glans/shaft and anal\n\nFemale:Three swabs were used to collect exfoliated skin cells from the vaginaļ¼vulva and anal'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4691}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-05', 'studyFirstSubmitDate': '2014-07-09', 'studyFirstSubmitQcDate': '2014-07-09', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence and incidence of HPV infection', 'timeFrame': '1 year', 'description': 'Evaluate the prevalence and incidence of HPV infection and related diseases in subjects'}], 'secondaryOutcomes': [{'measure': 'risk factors of HPV infection and related diseases', 'timeFrame': '1 year', 'description': 'Analyze risk factors of HPV infection and related diseases.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HPV', 'genital warts'], 'conditions': ['Human Papillomavirus Infection', 'Genital Warts']}, 'referencesModule': {'references': [{'pmid': '30852604', 'type': 'DERIVED', 'citation': 'Wei F, Guo M, Huang S, Li M, Cui X, Su Y, Wu X, Ma X, Zheng Y, Huang Y, Wang L, Pan L, Wu T, Zhang J, Xia N. Sex Differences in the Incidence and Clearance of Anogenital Human Papillomavirus Infection in Liuzhou, China: An Observational Cohort Study. Clin Infect Dis. 2020 Jan 1;70(1):82-89. doi: 10.1093/cid/ciz168.'}]}, 'descriptionModule': {'briefSummary': 'primary purpose:Evaluate the prevalence and incidence of HPV infection and related diseases in subjects.\n\nSecondary purpose:Analyze risk factors of HPV infection and related diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '5000 healthy volunteers will be recruited from the residents of Liuzhou through advertisment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 18 to 55 years;\n* residents of the study site;\n* at least one sex partner;\n* Be able to understand and comply with the request of the protocol.\n\nExclusion Criteria:\n\n* pregnant;\n* has received HPV vaccines.'}, 'identificationModule': {'nctId': 'NCT02188004', 'briefTitle': 'The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen University'}, 'officialTitle': 'The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases In Male and Female Aged Over 18 Years In China', 'orgStudyIdInfo': {'id': 'HPV-EPI-001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Liuchow', 'state': 'Guangxi', 'country': 'China', 'facility': 'Liuzhou Center of disease prevention and control', 'geoPoint': {'lat': 24.32405, 'lon': 109.40698}}], 'overallOfficials': [{'name': 'Jun Zhang', 'role': 'STUDY_CHAIR', 'affiliation': 'Xiamen University'}, {'name': 'Ming-Qiang Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liuzhou center of disease prevention and control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jun Zhang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Liuzhou center of disease prevention and control', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jun Zhang', 'investigatorAffiliation': 'Xiamen University'}}}}