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

Not yet recruiting

• Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia

• Registration Number: NCT06866392
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Start: 2025-03-15
• Primary Completion: 2027-03-15
• Study Completion: 2028-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 4200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.