NCT07259616

Incidence of Cervical Cancer in HPV-positive Women With Low-grade Cytological Abnormalities

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46,079 (actual)
• Sponsor: Gynaecologisch Oncologisch Centrum Zuid · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to assess the five-year incidence of histologically confirmed cervical cancer among women who test positive for human papillomavirus (HPV) with low-grade cytological abnormalities, to evaluate whether follow-up intensity could be reduced in women participating in the Dutch population-based cervical cancer screening program who are HPV-positive and have low-grade cytological abnormalities - atypical squamous cells of undetermined significance (ASC-US), atypical glandular cells of endocervical origin (AGC), or low-grade squamous intraepithelial lesions (LSIL). The main questions it aims to answer are: What is the five-year risk of developing cervical cancer in HPV-positive women with low-grade cytological abnormalities? Does the presence of subsequent low-grade cytology affect the five-year risk of cervical cancer in this population? Researchers will compare the risk of cervical cancer in HPV-positive women with low-grade abnormalities to women with stable negative for intraepithelial lesion or malignancy (NILM) cytology, since women with stable NILM are discharged from further follow-up back to the screening programme. This will help evaluate whether follow-up intensity can be reduced in women with low-grade abnormalities.

Conditions

• Cervical Intraepithelial Neoplasia
• Cervix Uteri Cancer
• Human Papilloma Virus
• Cervix Carcinoma
• Cervix; Intraepithelial Neoplasia

Timeline

• Start date: 2017-01-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2025-12-02
• Last updated: 2025-12-02