Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT06366516
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Methylation Test Triage in HPV Positive Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}, {'id': 'D065311', 'term': 'Adenocarcinoma in Situ'}], 'ancestors': [{'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003127', 'term': 'Colposcopy'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Women who aged 25 to 65 years are screened for cervical cancer and they are all positive of high-risk HPV.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-13', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-04-13', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity and specificity of methylation test in detecting CIN2+.', 'timeFrame': 'From date of enrollment until the date of first documented CIN2+,assessed up to 12 months', 'description': 'The primary variable of methylation test are as follows:clinical sensitivity, clinical specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, positive coincidence rate, and negative coincidence rate.'}], 'secondaryOutcomes': [{'measure': 'KAPPA value of methylation test.', 'timeFrame': 'From date of enrollment until the date of first documented CIN2+,assessed up to 12 months', 'description': 'KAPPA value is the secondary variable of methylation test which need to meet statistical criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human papillomavirus', 'High-grade squamous intraepithelial lesion', 'Methylation', 'Cervical cancer screening', 'Triage', 'Adenocarcinoma in Situ', 'Cytology'], 'conditions': ['Precancerous Cervical Lesion']}, 'referencesModule': {'references': [{'pmid': '32619334', 'type': 'BACKGROUND', 'citation': 'Kremer WW, Steenbergen R, Heideman D, Kenter GG, Meijer C. The use of host cell DNA methylation analysis in the detection and management of women with advanced cervical intraepithelial neoplasia: a review. BJOG. 2021 Feb;128(3):504-514. doi: 10.1111/1471-0528.16395. Epub 2020 Aug 9.'}, {'pmid': '32745170', 'type': 'RESULT', 'citation': 'Giorgi Rossi P, Carozzi F, Ronco G, Allia E, Bisanzi S, Gillio-Tos A, De Marco L, Rizzolo R, Gustinucci D, Del Mistro A, Frayle H, Confortini M, Iossa A, Cesarini E, Bulletti S, Passamonti B, Gori S, Toniolo L, Barca A, Bonvicini L, Mancuso P, Venturelli F, Benevolo M; the New Technology for Cervical Cancer 2 Working Group. p16/ki67 and E6/E7 mRNA Accuracy and Prognostic Value in Triaging HPV DNA-Positive Women. J Natl Cancer Inst. 2021 Mar 1;113(3):292-300. doi: 10.1093/jnci/djaa105.'}, {'pmid': '35266975', 'type': 'RESULT', 'citation': 'van den Helder R, Steenbergen RDM, van Splunter AP, Mom CH, Tjiong MY, Martin I, Rosier-van Dunne FMF, van der Avoort IAM, Bleeker MCG, van Trommel NE. HPV and DNA Methylation Testing in Urine for Cervical Intraepithelial Neoplasia and Cervical Cancer Detection. Clin Cancer Res. 2022 May 13;28(10):2061-2068. doi: 10.1158/1078-0432.CCR-21-3710.'}, {'pmid': '37047452', 'type': 'RESULT', 'citation': 'Dovnik A, Poljak M. The Role of Methylation of Host and/or Human Papillomavirus (HPV) DNA in Management of Cervical Intraepithelial Neoplasia Grade 2 (CIN2) Lesions. Int J Mol Sci. 2023 Mar 30;24(7):6479. doi: 10.3390/ijms24076479.'}, {'pmid': '37894462', 'type': 'RESULT', 'citation': 'Mazurec K, Trzeszcz M, Mazurec M, Streb J, Halon A, Jach R. Triage Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based Cervical Cancer Screening: p16/Ki67 Dual Stain vs. Cytology. Cancers (Basel). 2023 Oct 21;15(20):5095. doi: 10.3390/cancers15205095.'}, {'pmid': '32408396', 'type': 'RESULT', 'citation': 'Yang S, Wu Y, Wang S, Xu P, Deng Y, Wang M, Liu K, Tian T, Zhu Y, Li N, Zhou L, Dai Z, Kang H. HPV-related methylation-based reclassification and risk stratification of cervical cancer. Mol Oncol. 2020 Sep;14(9):2124-2141. doi: 10.1002/1878-0261.12709. Epub 2020 Jun 2.'}, {'pmid': '31490545', 'type': 'RESULT', 'citation': 'Stoler MH, Baker E, Boyle S, Aslam S, Ridder R, Huh WK, Wright TC Jr. Approaches to triage optimization in HPV primary screening: Extended genotyping and p16/Ki-67 dual-stained cytology-Retrospective insights from ATHENA. Int J Cancer. 2020 May 1;146(9):2599-2607. doi: 10.1002/ijc.32669. Epub 2019 Oct 6.'}, {'pmid': '34536311', 'type': 'RESULT', 'citation': 'Wright TC Jr, Stoler MH, Ranger-Moore J, Fang Q, Volkir P, Safaeian M, Ridder R. Clinical validation of p16/Ki-67 dual-stained cytology triage of HPV-positive women: Results from the IMPACT trial. Int J Cancer. 2022 Feb 1;150(3):461-471. doi: 10.1002/ijc.33812. Epub 2021 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening.', 'detailedDescription': 'The study is divided into two phases, a baseline (cross-sectional) phase and a 1-year follow-up phase. Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study. Participants who do not meet the primary endpoint/treat at baseline will invited to participate in the follow-up phase of the trial. Participants included in the follow-up phase are underwent HPV, cytology, and methylation tests at 6 months and 1 year after baseline.Similar to the baseline phase,participants were referred to colposcopy/biopsy if any of the cytology and HPV tests result is positive.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'The aim of this study is to evaluate the value of methylation test in high-risk HPV positive women who aged 25 to 65 years for detecting high-grade cervical lesions and cervical cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 25\\~65 years undergoing cervical cancer screening\n* normal for cytology and positive for hrHPV\n* informed consent was obtained\n\nExclusion Criteria:\n\n* pregnant\n* with a known history of ablation or treatment with cervical excision within 12 months\n* hysterectomy\n* chemoradiotherapy\n* planning to participate or taking part in another cancer screening, treatment, or vaccination study\n* do not meet the inclusion criteria\n* give up the trial or naturally dropped out of the follow-up during the observation process\n* people who asked to withdraw'}, 'identificationModule': {'nctId': 'NCT06366516', 'acronym': 'MTTRIHPW', 'briefTitle': 'Role of Methylation Test Triage in HPV Positive Women', 'organization': {'class': 'OTHER', 'fullName': 'Obstetrics & Gynecology Hospital of Fudan University'}, 'officialTitle': 'Clinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China', 'orgStudyIdInfo': {'id': 'FUOBGY2024-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women aged 25-65 years with high-risk HPV infection.', 'description': 'Ten thousand women were recruited who aged 25-65 years and they are positive for high-risk HPV.', 'interventionNames': ['Diagnostic Test: Methylation Test']}], 'interventions': [{'name': 'Methylation Test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Liquid-based Cytology Test', 'High-risk HPV test', 'Colposcopy', 'Biopsy'], 'description': 'Participants who aged 25-65 years with high-risk HPV infection are recruited.To start with,cervical exfoliated cells are collected, coded (according to the actual enrollment sequence), and stored in the pathology department where methylation testing is performed.In addition,patients will underwent colposcopy and biopsy.\n\nPatients are followed up by cytology, high-risk HPV and methylation tests at 6 and 12 months after enrollment.Cervical conization and hysterectomy will be taken if necessary according to histopathological results. The clinical endpoint is reached when CIN2+ is confirmed by histopathological result.', 'armGroupLabels': ['Women aged 25-65 years with high-risk HPV infection.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Long Sui, Professor', 'role': 'CONTACT', 'email': 'suilong@fudan.edu.cn', 'phone': '0086-021-33189900'}, {'name': 'Qing Cong, PHD', 'role': 'CONTACT', 'email': 'qingcong@fudan.edu.cn', 'phone': '0086-021-33189900'}], 'facility': 'Obstetrics and Gynecology Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Long Sui, Professor', 'role': 'CONTACT', 'email': 'suilong@fudan.edu.cn', 'phone': '0086-021-33189900'}, {'name': 'Qing Cong, PHD', 'role': 'CONTACT', 'email': 'qingcong@fudan.edu.cn', 'phone': '0086-021-33189900'}], 'overallOfficials': [{'name': 'Long Sui, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Obstetrics & Gynecology Hospital of Fudan University'}, {'name': 'Lan Zhu, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'All collected data from participants will be shared，including age of patients, the results of cytological examination/high-risk HPV genotyping/methylation test/histopathological, colposcopy impression, and whether cervical conization or hysterectomy were performed before.', 'accessCriteria': "We will apply for a web address to upload all collected clinical data and trial results. The public can send email or request access to the web if any of them needed. After waiting for the principal investigator's consent, the data would be shared by browsing the website."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obstetrics & Gynecology Hospital of Fudan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': "Chengdu Women's and Children's Central Hospital", 'class': 'OTHER'}, {'name': 'Guangdong Women and Children Hospital', 'class': 'OTHER'}, {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}