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NCT07259616Completed

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

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
46079 (actual)
First submitted
24 Sept 2025
Start date
1 Jan 2017
Primary completion date
31 Dec 2023
Lead sponsor
Gynaecologisch Oncologisch Centrum Zuid
NCT number
NCT07259616

What you commit to

  • Study type: Observational
  • Participants enrolled: 46079
  • From 1 Jan 2017 to the primary completion date, 31 Dec 2023
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • None

Who the study is looking for

  • 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.

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.