NCT06366516

Role of Methylation Test Triage in HPV Positive Women

Clinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,000 (estimated)
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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 Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study.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.

Conditions

• Precancerous Cervical Lesion

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-08-01
• Completion: 2026-02-01
• First posted: 2024-04-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: China