Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-01 @ 3:04 PM
Study NCT ID:
NCT05085093
Status:
UNKNOWN
Last Update Posted:
2021-10-20
First Post:
2021-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protective Efficacy of HPV Vaccination After Treatment of HPV Related Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053918', 'term': 'Papillomavirus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 414}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2021-10-17', 'studyFirstSubmitQcDate': '2021-10-19', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence', 'timeFrame': '6 months after operation', 'description': 'If The lesions were found again more than 6 months after operation (pathological diagnosis)'}, {'measure': 'Persistent HPV infection', 'timeFrame': 'At least 12 months', 'description': 'At least 12 months apart, cervical vaginal / external genital swabs or tissue biopsies were taken for 2 or more consecutive times, and HPV detection and analysis showed that the same HPV type was positive'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HPV Vaccination、HPV Related Diseases、Protective Efficacy']}, 'descriptionModule': {'briefSummary': 'To understand the HPV infection status and subtype distribution of patients, and to study the protective effect of prophylactic HPV vaccination on the recurrence of HPV related diseases after treatment through a prospective cohort study. To provide data support for the primary prevention of HPV related diseases in Chinese women after treatment, and to analyze the related factors of HPV related disease recurrence and HPV continuous positive.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with HPV related diseases', 'genderDescription': 'The diseases in this study mainly occurred in female groups', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Women aged 18-45, of childbearing age or before perimenopause (patients without pregnancy plan within two years); 2. Patients diagnosed as condyloma acuminatum, vaginal intraepithelial lesions (high-grade and low-grade lesions), cervical intraepithelial lesions (high-grade and low-grade lesions), vulvar intraepithelial lesions (high-grade and low-grade lesions), cervical cancer (IA1-IIA2 stage) and treated within 3 months; 3. No surgical contraindications such as severe center of heart, lung and other organ dysfunction and abnormal hemagglutination; 4. Fully know the treatment method, sign informed consent, and actively cooperate with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Participating in other clinical trials; 2. Use immunoglobulin or blood products within 3 months before vaccination; 3. Hypersensitivity to vaccine active ingredients or any dressing ingredients; 4. Acute stage of moderate and severe diseases; 5. Acute stage of severe immune deficiency diseases and autoimmune diseases; 6. Pregnant women and lactating patients; 7. Patients with planned pregnancy within 2 years; 8. Less than 18 years old and more than 45 years old.'}, 'identificationModule': {'nctId': 'NCT05085093', 'briefTitle': 'Protective Efficacy of HPV Vaccination After Treatment of HPV Related Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Protective Efficacy of HPV Vaccination After Treatment of HPV Related Diseases', 'orgStudyIdInfo': {'id': 'KY20212121'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'HPV vaccine group', 'interventionNames': ['Biological: HPV vaccine']}, {'label': 'Control group', 'description': 'non HPV vaccine group'}], 'interventions': [{'name': 'HPV vaccine', 'type': 'BIOLOGICAL', 'description': 'Patients choose to be vaccinated or not to be vaccinated with HPV vaccine according to their own wishes', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'The First Affiliated Hospital, Air Force Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'hong Yang, professional', 'role': 'STUDY_CHAIR', 'affiliation': "The First Affiliated Hospital，Air Force Medical University,Xi'an, Shaanxi, China"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "We haven't decided whether to share the data yet"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}