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

November 20, 2025 updated by: Jurgen M.J. Piek, Gynaecologisch Oncologisch Centrum Zuid

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

46079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This retrospective cohort study included women who participated in the population-based cervical cancer screening program in the Netherlands between January 2017 and December 2018. Eligible participants were HPV-positive and had 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) or stable negative for intra-epithelial leasion or malignancy (NILM) cytology results after one year according to the Bethesda system.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort low-grade cytological abnormalities
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment up to 5 years after.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to diagnosis of cervical carcinoma
Time Frame: From enrollment up to 5 years after.
Time from enrollment to diagnosis of cervical carcinoma
From enrollment up to 5 years after.
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.
From enrollment up to 5 years after.
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
Moment of diagnosis of cervical carcinoma from enrollment up to 5 years after.
Carcinoma subtype
Time Frame: Moment of diagnosis of cervical carcinoma within 5 years after enrollment.
Histological characteristics of carcinoma (subtype).
Moment of diagnosis of cervical carcinoma within 5 years after enrollment.
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 +).
From enrollment up to 5 years after.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynaecologisch Oncologisch Centrum Zuid

Collaborators

Maastricht University
Amphia Hospital
PALGA foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOCZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not have ownership of the individual participant data. Data can be obtained on request at https://aanvraag.palga.nl/login

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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