Role of Methylation Test Triage in HPV Positive Women
- Conditions
- Precancerous Cervical Lesion
- Interventions
- Diagnostic Test: Methylation Test
- Registration Number
- NCT06366516
- Lead Sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Brief 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.
- Detailed Description
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 Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study.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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 10000
- aged 25~65 years undergoing cervical cancer screening
- normal for cytology and positive for hrHPV
- informed consent was obtained
- pregnant
- with a known history of ablation or treatment with cervical excision within 12 months
- hysterectomy
- chemoradiotherapy
- planning to participate or taking part in another cancer screening, treatment, or vaccination study
- do not meet the inclusion criteria
- give up the trial or naturally dropped out of the follow-up during the observation process
- people who asked to withdraw
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Women aged 25-65 years with high-risk HPV infection. Methylation Test Ten thousand women were recruited who aged 25-65 years and they are positive for high-risk HPV.
- Primary Outcome Measures
Name Time Method The sensitivity and specificity of methylation test in detecting CIN2+. From date of enrollment until the date of first documented CIN2+,assessed up to 12 months 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.
- Secondary Outcome Measures
Name Time Method KAPPA value of methylation test. From date of enrollment until the date of first documented CIN2+,assessed up to 12 months KAPPA value is the secondary variable of methylation test which need to meet statistical criteria.
Trial Locations
- Locations (1)
Obstetrics and Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China