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Role of Methylation Test Triage in HPV Positive Women
Sponsor: Obstetrics & Gynecology Hospital of Fudan University
Summary
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.
Official title: Clinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China
Key Details
Gender
FEMALE
Age Range
25 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
10000
Start Date
2024-04
Completion Date
2026-02
Last Updated
2024-04-16
Healthy Volunteers
No
Conditions
Interventions
Methylation Test
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. Patients 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.
Locations (1)
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China