Clinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- The sensitivity and specificity of methylation test in detecting CIN2+.
Study Overview
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 Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study.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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged 25~65 years undergoing cervical cancer screening
- •normal for cytology and positive for hrHPV
- •informed consent was obtained
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
The sensitivity and specificity of methylation test in detecting CIN2+.
Time Frame: 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 Outcomes
- KAPPA value of methylation test.(From date of enrollment until the date of first documented CIN2+,assessed up to 12 months)