Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-21 @ 6:19 AM
Study NCT ID:
NCT02576158
Status:
UNKNOWN
Last Update Posted:
2017-06-27
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HPV Integration Testing for Cervical Cancer Screening
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'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-24', 'studyFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2015-10-12', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN)with comparison to HPV testing or TCT', 'timeFrame': '14 Months'}]}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Cervical Intraepithelial Neoplasia']}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy women between the ages of 30 and 65 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen aged 30-65 years old Attending the China population-based organised cervical screening program\n\nExclusion Criteria:\n\n1. Not providing informed consent\n2. previously confirmed CIN, cervical cancer, or other malignancies\n3. previous therapeutic procedure to cervix\n4. pregnancy'}, 'identificationModule': {'nctId': 'NCT02576158', 'briefTitle': 'HPV Integration Testing for Cervical Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'HPV（Human Papillomavirus） Integration Testing for Cervical Cancer Screening', 'orgStudyIdInfo': {'id': 'CCS-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects will be women, 30-65 years of age', 'description': 'Patients who are at average risk of developing cervical intraepithelial neoplasia or cervical cancer who are eligible for cervical cancer screening will be asked to collect Cervical Exfoliated Cells sample for the HPV integration screening test and for the HPV testing and TCT. Subjects with HPV positive will undergo colposcopy within 90 days of enrollment.', 'interventionNames': ['Procedure: TCT，HPV，colposcopic inspection']}], 'interventions': [{'name': 'TCT，HPV，colposcopic inspection', 'type': 'PROCEDURE', 'armGroupLabels': ['Subjects will be women, 30-65 years of age']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuyan Mao, MD', 'role': 'CONTACT', 'email': 'maoyy3@yahoo.com.cn', 'phone': '13989816955'}], 'facility': "Women's Hospital, School of Medicine, Zhejiang University", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Danhui Weng, MD, PhD', 'role': 'CONTACT', 'email': 'weng.dh@gmail.com', 'phone': '+862783662681'}], 'overallOfficials': [{'name': 'Ding Ma, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Ding Ma', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}