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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Methylation test and colposcopic biopsy, and clinical follow-up based on methylation results | ||
| OITS group | The experimental group underwent methylation test and colposcopic biopsy and OITS, and clinical follow-up was conducted according to methylation results and OITS results |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| photoelectric detection | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of a photoelectric image detector for cervical lesions | Sensitivity and specificity of the photoelectric detection technique relative to histopathological findings. | Enrolled subjects receive histopathological results approximately 7 days after colposcopy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Enrolled subjects receive histopathological results approximately 7 days after colposcopy. |
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Inclusion Criteria:
Exclusion Criteria:
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There are 30 multi-center units in the country, and each center competes to enter the group. The accuracy of OITS early data was 75%, the sensitivity was 82%, and the specificity was 63%. According to 20% shedding, possible causes of shedding: error caused by severe inflammatory patients, error caused by improper operation or subjects unwilling to cooperate with follow-up. The optimal efficacy test was performed with the rate of 0.75 in the experimental group and 0.5 in the control group, and the optimal efficacy threshold was 0.1(control-experimental group), bilateral alpha was 0.05, beta was 0.2, and the sample size ratio of the two groups was 1(experimental group: Control group), each single center needs to collect 58 cases in the experimental group and 58 cases in the control group. Considering 20% shedding, the sample size of each single center is at least 70 cases in the experimental group and 70 cases in the control group, and a total of 4200 cases of all centers.
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |