Clinical Trial

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

Study acronym: CC-AZ
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT06866392
Lead Sponsor Peking Union Medical College Hospital
Conditions Cervical Cancer, Cervical Intraepithelial Neoplasia
Enrollment 4,200 participants
Start Date 2025-03-15
Primary Completion 2027-03-15 (estimated)
Study Completion 2028-03-15 (estimated)
Updated on ClinicalTrials.gov 2025-03-10