Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-30 @ 10:20 PM
Study NCT ID:
NCT04333212
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2020-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'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': '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2014-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2020-04-01', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement', 'timeFrame': 'within one week after sample collected by a study physician', 'description': 'agreement, sensitivity, and specificity compared to DNA sequencing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Intraepithelial Neoplasia', 'Human Papillomavirus Infection', 'HPV Infection']}, 'descriptionModule': {'briefSummary': 'High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer. HPV testing and risk stratification by genotyping has been recognized as an effective cervical screening program. A chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA sequencing as the gold standard.', 'detailedDescription': 'High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer. HPV testing and risk stratification by genotyping has been recognized as an effective cervical screening program. HPV detection is also applied for triage of atypical squamous cells of undetermined significance and follow-up after treatment for cervical neoplasms. A chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA sequencing as the gold standard.\n\nOne-thousand one-hundred and three (1103) subjects were enrolled between December 2012 and December 2013 from Linkou Chang Gung Memorial Hospital, Mackay Memorial Hospital, Changhua Christian Hospital, and Cathay General Hospital.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'HPV detection and typing for exfoliated cervical cells', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 21-65 y/o female with sexual exposure\n2. Written informed consent\n3. Either one of the following conditions:\n\n3a. No previous history of abnormal cervical cytology or abnormal histology for women enrolled in no intraepithelial lesion or malignancy (NILM) group 3b. Abnormal cervical cytology other than atrophic change, reactive change or glandular cells favored of the endometrial origin\n\nExclusion Criteria:\n\n1. Current pregnancy\n2. Previous total hysterectomy\n3. Cervicovaginal infection required treatment\n4. Received cervical ablative therapy within 1 year'}, 'identificationModule': {'nctId': 'NCT04333212', 'briefTitle': 'HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Human Papillomavirus Detection and Genotyping by DR. HPV Genotyping IVD Kit in Exfoliated Cells of the Uterine Cervix', 'orgStudyIdInfo': {'id': 'MA1103L9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'study arm', 'description': 'We projected a total of 1,100 study cases, which encompassed 100 cases of women with no intraepithelial lesion or malignancy (NILM) cytology, 300 cases of ASCUS, 300 cases of low grade squamous intraepithelial lesion (LSIL) and 400 cases high grade squamous intraepithelial lesion (HSIL) in cervical cytology.', 'interventionNames': ['Device: DR. Chip HPV genotyping IVD kit']}], 'interventions': [{'name': 'DR. Chip HPV genotyping IVD kit', 'type': 'DEVICE', 'description': 'HPV typing by gene chip', 'armGroupLabels': ['study arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50006', 'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'zip': '104', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Mackay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '106', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Cathay General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '33305', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '3 months after accepting for report publication', 'ipdSharing': 'YES', 'description': 'For clinical trial participation', 'accessCriteria': 'to the public'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr. Chip Biotechnology Incorporation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairperson', 'investigatorFullName': 'TING-CHANG CHANG', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}