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

NCT ID: NCT06866392

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 4200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2028-03-15

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.

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

control group

Methylation test and colposcopic biopsy, and clinical follow-up based on methylation results

No interventions assigned to this group

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

photoelectric detection

Intervention Type: 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.

Interventions

photoelectric 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CCAZ

Identifier Type: -

Identifier Source: org_study_id