Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-17 @ 7:12 PM
Study NCT ID:
NCT06631495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
All-cause and Diseases-specific Mortality of High-risk HPV Infection
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-06', 'studyFirstSubmitDate': '2024-08-29', 'studyFirstSubmitQcDate': '2024-10-06', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HR-HPV infection AND all-cause and diseases-specific mortality', 'timeFrame': 'one year', 'description': 'all-cause and diseases-specific mortality of HR-HPV infection'}], 'secondaryOutcomes': [{'measure': 'time-period of HR-HPV infection AND all-cause and diseases-specific mortality', 'timeFrame': 'one year', 'description': 'all-cause and diseases-specific mortality of time-period of HR-HPV infection'}, {'measure': 'HR-HPV type AND all-cause and diseases-specific mortality', 'timeFrame': 'one year', 'description': 'all-cause and diseases-specific mortality of HR-HPV type'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HPV Infection']}, 'descriptionModule': {'briefSummary': 'The corresponding prevention strategies and treatment routes of HPV infection can be provided through investigating causes of death due to HPV infection and specialized diseases.', 'detailedDescription': "Anxiety and panic about HPV infection have become common phenomena in tumor screening. Transitional and useless diagnosis and treatment caused by HPV infection are also common, affecting women's physical and mental health and health economic level. If the investigators can understand the causes of death related to HPV infection and specialized diseases, the investigators can provide corresponding prevention strategies and treatment routes from the level of health policies and individual methods and mechanisms, and also alleviate the related panic caused by HPV infection."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female participate in cervical cancer screening', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female participate in at least once cervical cancer screening with clear information of HPV DNA test results;\n2. Having clear identification (ID number or others) that can be retrieved in the cause of death database.\n\nExclusion Criteria:\n\nCases that do not fully meet all inclusion criteria are used as exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT06631495', 'briefTitle': 'All-cause and Diseases-specific Mortality of High-risk HPV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'All-cause and Diseases-specific Mortality of High-risk HPV Infection', 'orgStudyIdInfo': {'id': 'HPV-ADM1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HPV infection', 'description': 'patients with HPV infection', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'not available-observation study', 'armGroupLabels': ['HPV infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Lei Li', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '+86-13911988831'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Li, doctor', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '13911988831'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Lei Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}