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.
Study Type
OBSERVATIONAL
Enrollment
4,200
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.
Sensitivity and specificity of a photoelectric image detector for cervical lesions
Sensitivity and specificity of the photoelectric detection technique relative to histopathological findings.
Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy
Detection rate of CIN2+ by photoelectric cervical lesion image detector
The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared with the results of Methylaiton, colpscopy, HPV detection and cytology.
Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
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