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

Gynaecologisch Oncologisch Centrum Zuid

Status: Completed

Conditions: Human Papilloma Virus; Cervix Carcinoma; Cervix; Intraepithelial Neoplasia; Cervical Intraepithelial Neoplasia; Cervix Uteri Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07259616

GOCZ

Details and patient eligibility

About

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.

Enrollment: 46,079 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

Women who participated in the cervical cancer screening program in the Netherlands between January 2017 and December 2018, who:

• Tested HPV-positive with cytology results categorized as atypical squamous cells of undetermined significance (ASC-US), atypical glandular cells of endocervical origin (AGC), or low-grade squamous intraepithelial lesion (LSIL) according to the Bethesda system, or
• Were HPV-positive and had stable negative for intra-epithelial leasion or malignancy (NILM) cytology after one year.

Exclusion criteria

• None

Trial design

46,079 participants in 2 patient groups

Cohort low-grade cytological abnormalities

Description:

Women who participated in the population-based cervical cancer screening program in the Netherlands between January 2017 and December 2018 who were HPV positive and with cytology results atypical squamous cells of undetermined significance (ASC-US), atypical glandular cells of endocervical origin (AGC), or low-grade squamous intraepithelial lesion (LSIL) according to the Bethesda system.

Cohort HPV positive and no cervical abnormalities

Description:

Women who participated in the population-based cervical cancer screening program in the Netherlands between January 2017 and December 2018 who were HPV positive and with a stable cytology result negative for intra-epithelial neoplasia according to the Bethesda system.