NCT06866392

Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection and Epigenetic Procotol

Study on Novel Strategies for Cervical Cancer Screening Using Photoelectric Detection Combined with Epigenetic Procotol

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,200 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A national multicenter, open randomized controlled study was conducted. It is planned to invite 30 multi-center units across the country to compete for enrollment, and each multi-center will enroll 140 patients meeting colposcopic indications (70 in the conventional group and 70 in the experimental group), totaling 4200 patients. Enrolled subjects were randomly divided into two groups. Methylation test + colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test + colposcopic biopsy +OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results. To verify the effectiveness of methylation tests and OITS in screening for CIN2+, whether they can reduce missed diagnosis of CIN2+, whether they can flag excessive colposcopic procedures, and the value of clinical follow-up for cervical lesions.

Conditions

• Cervical Cancer
• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	photoelectric detection	Methylation test and colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test and colposcopic biopsy and OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results.

Timeline

• Start date: 2025-03-15
• Primary completion: 2027-03-15
• Completion: 2028-03-15
• First posted: 2025-03-10
• Last updated: 2025-03-10