NCT07298707

Cervical Cytology DNA Methylation for Endometrial Lesion Screening and Follow-up

A Multicenter Study on Cervical Cytology DNA Methylation for Screening and Follow-up of Endometrial Lesions

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,500 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to evaluate the accuracy of a novel molecular test for screening and monitoring endometrial lesions in women at medium-to-high risk for endometrial cancer. The main questions it aims to answer are: * What is the sensitivity and specificity of the CISENDO test (a DNA methylation test on cervical cytology samples) for detecting histologically confirmed endometrial intraepithelial neoplasia (EIN) or invasive endometrial cancer? * How do DNA methylation levels change during the follow-up of endometrial lesions? Researchers will compare the results of the CISENDO test to the results from the standard diagnostic procedure (hysteroscopy with histology) to see if the molecular test can reliably identify high-risk lesions and track disease progression. Participants will: * Provide a residual liquid-based cervical cytology sample for the CISENDO test. * Undergo a standard diagnostic hysteroscopy examination (with or without biopsy) for comparison. * Some participants will return for follow-up visits at 6 and 12 months for repeat methylation testing and/or hysteroscopy to monitor their condition.

Conditions

• Endometrial Neoplasms
• DNA Methylation
• Cervical Smears
• Early Detection of Cancer
• Endometrial Hyperplasia

Timeline

• Start date: 2026-01-10
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2025-12-23
• Last updated: 2025-12-23