Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT06859151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2025-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DNA Methylation and the Increased Risk of Cervical Cancer Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], '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': '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biospecimen will include vaginal swabs, cervical exfoliated cells from reproductive tract of the volunteers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in DNA methylation of cervical epithelial cells', 'timeFrame': 'Baseline (enrollment period)', 'description': 'Changes in DNA methylation of cervical epithelial cells'}], 'secondaryOutcomes': [{'measure': 'Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens', 'timeFrame': 'Baseline (enrollment period)', 'description': 'Cervical lesions (including different stages of development: normal, CIN 1, CIN 2, CIN 3, and cervical cancer), and sexually transmitted pathogens.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Papillomavirus Infections']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the correlation between reproductive tract microbiota and DNA methylation in cervical epithelial cells, as well as its impact on the development of cervical cancer, through a paired case-control clinical study', 'detailedDescription': "This study is a multicenter matched case-control study. The inclusion and exclusion criteria are verified by collecting HPV test results, TCT examination results, and for the case group, participants' histopathological results are also collected. Participants who meet the inclusion and exclusion criteria have their HPV DNA test original secretion samples and TCT examination original cervical scrape cell samples (preserved in RNA preservative solution) collected. Enrollment involves dividing the samples into a discovery cohort of 800 cases and a validation cohort of 1200 cases. The discovery cohort undergoes multi-target DNA methylation testing, STDs pathogen testing, HPV E6/E7 testing, and metagenomic sequencing; the validation cohort undergoes PCR validation of DNA methylation sites related to cervical cancer, STDs pathogen testing, HPV E6/E7 testing, and metagenomic sequencing"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 18 to 50', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-50 years old, with a history of sexual activity\n2. HPV and TCT tests are performed concurrently in the gynecology clinic\n3. Those with abnormal HPV and TCT test results undergo tissue pathological testing\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding\n2. Patients with immunological disorders or severe autoimmune diseases, such as AIDS, SLE\n3. Those who have had organ transplants or are currently using immunosuppressive agents\n4. Use of vaginal douching within 48 hours before sample collection\n5. Use of vaginal probiotics within one month before sample collection\n6. Use of vaginal antibiotics or antifungal treatments within one month before sample collection\n7. History of surgery related to cervical intraepithelial neoplasia (CIN), including but not limited to conization of the cervix, LEEP procedures, etc.\n8. Blood samples (avoid sampling during menstruation), insufficient remaining sample volume to support subsequent analysis needs, and samples not stored as required.'}, 'identificationModule': {'nctId': 'NCT06859151', 'briefTitle': 'DNA Methylation and the Increased Risk of Cervical Cancer Development', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'The Role of the Genital Tract Microbiota in Cervical Epithelial Cell DNA Methylation and the Increased Risk of Cervical Cancer Development', 'orgStudyIdInfo': {'id': 'CALM2501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'HPV16(-) HPV18(-) TCT(-)', 'interventionNames': ['Other: Reproductive tract microbiota']}, {'label': 'Case group 1', 'description': 'HPV16(+) /HPV18(+) TCT(-) CIN\\<2', 'interventionNames': ['Other: Reproductive tract microbiota']}, {'label': 'Case group 2', 'description': 'HPV16(+) /HPV18(+) TCT(+) CIN\\<2', 'interventionNames': ['Other: Reproductive tract microbiota']}, {'label': 'Case group 3', 'description': 'HPV16(+) /HPV18(+) TCT(+) CINā„2+', 'interventionNames': ['Other: Reproductive tract microbiota']}], 'interventions': [{'name': 'Reproductive tract microbiota', 'type': 'OTHER', 'description': 'Reproductive tract microbiota', 'armGroupLabels': ['Case group 1', 'Case group 2', 'Case group 3', 'control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Muxuan Chen, Doctor', 'role': 'CONTACT', 'email': 'muxuanchen@126.com', 'phone': '+8613580561916'}], 'overallOfficials': [{'name': 'Muxuan Chen, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Diagnostic Technician', 'investigatorFullName': 'Muxuan Chen', 'investigatorAffiliation': 'Zhujiang Hospital'}}}}