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Completed

NCT Number: NCT07259616

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

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Cervix Carcinoma Cervix Uteri Cancer Cervix; Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papilloma Virus Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

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 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

Treatment and study plan

Primary outcomes

  1. Five-year incidence cervical cancer

    Time frame: From enrollment up to 5 years after.

    Incidence of histologically confirmed cervical cancer within the five-year screening interval.

Secondary outcomes

  1. Time to diagnosis of cervical carcinoma

    Time frame: From enrollment up to 5 years after.

    Time from enrollment to diagnosis of cervical carcinoma

  2. All-cause mortality

    Time frame: From enrollment up to 5 years after.

    The number of participants that died from enrollment up to five years after, all causes of death included.

  3. Examination at which the diagnosis cervical carcinoma was established

    Time frame: Moment of diagnosis of cervical carcinoma from enrollment up to 5 years after.

    Type of examination at which the diagnosis was established

  4. Carcinoma subtype

    Time frame: Moment of diagnosis of cervical carcinoma within 5 years after enrollment.

    Histological characteristics of carcinoma (subtype).

  5. Incidence of cervical cancer within 5 years of inclusion stratified by histological diagnosis within three months of enrollment

    Time frame: From enrollment up to 5 years after.

    Incidence of cervical cancer within 5 years of inclusion stratified by histological diagnosis within three months of baseline abnormal cytology (≤ CIN I vs CIN 2+) and, for the ≤ CIN I group, fur-ther stratified by cytology at 12-month follow-up (no or nondiagnostic cytology, ≤ LSIL, HSIL +).

Sponsors and collaborators

Lead sponsor

Gynaecologisch Oncologisch Centrum Zuid

Other

Collaborators

  • Amphia Hospital
  • Maastricht University
  • PALGA foundation

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2025
Registry last updated
Dec 2, 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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