Improving Screening and Risk Assessment for HPV-Positive Women Aged 23 to 64 After Cervical Treatment and in Postmenopausal Women Aged 50 to 64

What this Trial Is About

Researchers are evaluating new ways to improve the screening and follow-up care for women who test positive for HPV, especially focusing on postmenopausal women aged 50 to 64 and women aged 23 to 64 after cervical lesion removal. The study compares different tests like cytology, extended genotyping, p16Ki67 dual stain cytology, DNA methylation, and viral load to better predict the risk of developing or returning cervical precancerous lesions called CIN2. The study uses residual cell samples from HPV-positive screening tests to perform these various triage markers including p16Ki67 dual stain, extended genotyping, and DNA methylation. Women who have undergone loop electrosurgical excision procedure LEEP for cervical lesions will be followed with HPV and cytology tests at six and twelve months to assess their risk of residual or recurrent disease. Any leftover samples after testing are stored for future research. Participants will have their screening and follow-up test results monitored to identify CIN2 or CIN3 lesions through cervical biopsies or cone biopsies at baseline and 1.5 years later. The study tracks the accuracy of different triage tests, HPV genotype distribution, and p16Ki67 positivity rates. This observational study lasts through the follow-up periods and focuses on improving risk stratification and reducing unnecessary procedures for HPV-positive women.

Screening Triage and Risk Stratification