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

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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Key information

Conditions

Cervical Cancer Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women between the ages of 18 and 65 who have already had sex life
HPV16, 18 positive or high-risk HPV infection with cytology ≧ASC-US
No history of cervical cancer and cervical physical therapy, a complete cervix
No menstrual period, no sexual activity and vaginal medication within 48 hours
The vagina or cervix is not in a stage of acute inflammation
Willing to participate in the study with full informed consent

Exclusion criteria

Cervical dysplasia (congenital malformation or double uterus, etc.)
History of cervical treatment (coning, ablation, or photodynamic therapy)
There are definite immunosuppression conditions, such as HIV infection or organ transplantation
Patients with severe bleeding diseases such as coagulation abnormalities or photosensitive diseases (such as porphyria, lupus erythematosus, etc.)
A history of radiation or chemotherapy (e.g., pelvic radiation therapy) with cancer at other sites
The patient is in pregnancy or puerperium
The other conditions of this study were not considered appropriate by the researchers

Treatment and study plan

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.

Primary outcomes

Sensitivity and specificity of a photoelectric image detector for cervical lesions

Time frame: Enrolled subjects receive histopathological results approximately 7 days after colposcopy

Sensitivity and specificity of the photoelectric detection technique relative to histopathological findings.

Secondary outcomes

Detection rate of CIN2+ by photoelectric cervical lesion image detector

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Acronym: CC-AZ

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Mar 10, 2025
Registry last updated: Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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