Cervical Cancer, Cervical Intraepithelial Neoplasia
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTphotoelectric 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.
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Women between the ages of 18 and 65 who have already had sex life 2. HPV16, 18 positive or high-risk HPV infection with cytology ≧ASC-US 3. No history of cervical cancer and cervical physical therapy, a complete cervix 4. No menstrual period, no sexual activity and vaginal medication within 48 hours 5. The vagina or cervix is not in a stage of acute inflammation 6. Willing to participate in the study with full informed consent
Exclusion criteria
1. Cervical dysplasia (congenital malformation or double uterus, etc.) 2. History of cervical treatment (coning, ablation, or photodynamic therapy) 3. There are definite immunosuppression conditions, such as HIV infection or organ transplantation 4. Patients with severe bleeding diseases such as coagulation abnormalities or photosensitive diseases (such as porphyria, lupus erythematosus, etc.) 5. A history of radiation or chemotherapy (e.g., pelvic radiation therapy) with cancer at other sites 6. The patient is in pregnancy or puerperium 7. The other conditions of this study were not considered appropriate by the researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of a photoelectric image detector for cervical lesions | Enrolled subjects receive histopathological results approximately 7 days after colposcopy | Sensitivity and specificity of the photoelectric detection technique relative to histopathological findings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of CIN2+ by photoelectric cervical lesion image detector | Enrolled subjects receive histopathological results approximately 7 days after colposcopy. | 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. |
Outcome results
None listed