Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT01058460
Status:
UNKNOWN
Last Update Posted:
2011-06-01
First Post:
2010-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-31', 'studyFirstSubmitDate': '2010-01-27', 'studyFirstSubmitQcDate': '2010-01-27', 'lastUpdatePostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histological CIN2, CIN3 and cervical carcinoma', 'timeFrame': 'At baseline and each subsequent follow-up'}], 'secondaryOutcomes': [{'measure': 'Clearance of mild cervical abnormalities among HPV negative subjects', 'timeFrame': 'At baseline and 1-year after'}]}, 'conditionsModule': {'keywords': ['Cervical Intraepithelial Neoplasia, Grade III', 'Cervical Intraepithelial Neoplasia, Grade II'], 'conditions': ['Cervical Cancer', 'Cervical Intraepithelial Neoplasia']}, 'descriptionModule': {'briefSummary': 'To compare the effects of conventional cytology testing with concommitant HPV-cytology testing for the detection of high grade cervical lesions in primary cervical cancer screening in Hong Kong\n\nHypotheses:\n\n1. There is a significant difference in the number of CIN2+ cases detected between the cytology testing group and the cytology-HPV co-testing group at baseline.\n2. Significantly more CIN2+ cases will be detected at the second round of screening among participants with normal cytology result in the control arm than those with normal cytology and negative HPV results in the intervention arm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ethnic Chinese women aged 30 to 60 years who have completed a written consent\n* Women who have not attended screening for the past 3 years or more will be given priority\n\nExclusion Criteria:\n\n* Currently pregnant\n* Without a cervix\n* Congenital abnormalities of the lower genital tract\n* Previous history of invasive cervical cancer\n* Who has been followed-up or treated for an abnormal cytology result in the past 12 months\n* Who are unable to provide consent'}, 'identificationModule': {'nctId': 'NCT01058460', 'acronym': 'COCY', 'briefTitle': 'HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Concomitant HPV-cytology Testing With Conventional Cytology Testing for the Detection of High Grade Cervical Intraepithelial Neoplasia in Primary Cervical Cancer Screening in Hong Kong', 'orgStudyIdInfo': {'id': 'UW09-377'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'cytology', 'description': 'Subjects in the control arm will receive conventional cytology testing and HPV testing at baseline. Follow up management will be based on the cytology result according to current practice.'}, {'type': 'EXPERIMENTAL', 'label': 'HPV-cytology', 'description': 'Subjects in the HPV-cytology arm will receive HPV testing and cytology testing at baseline. Follow up management will be based on both results.', 'interventionNames': ['Procedure: HPV-cytology co-testing']}], 'interventions': [{'name': 'HPV-cytology co-testing', 'type': 'PROCEDURE', 'description': 'Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.', 'armGroupLabels': ['HPV-cytology']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong SAR', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hextan YS Ngan, MD, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Obstetrics & Gynaecology, The University of Hong Kong'}], 'centralContacts': [{'name': 'Hextan YS Ngan, MD, MBBS', 'role': 'CONTACT', 'email': 'hysngan@hkusua.hku.hk', 'phone': '852-2255-4684'}], 'overallOfficials': [{'name': 'Hextan YS Ngan, MD, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics & Gynaecology, The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Family Planning Association of Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Professor Hextan Y.S. Ngan', 'oldOrganization': 'Department of Obstetrics & Gynaecology, The University of Hong Kong'}}}}