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

NCT07259616 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46079

Last updated 2025-12-02

No results posted yet for this study

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

Sponsors & Collaborators

  • PALGA foundation

    collaborator OTHER

  • Amphia Hospital

    collaborator OTHER

  • Maastricht University

    collaborator OTHER

  • Gynaecologisch Oncologisch Centrum Zuid

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07259616 on ClinicalTrials.gov