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Risk of Cervical Cancer Following Incident, Persistent and History-unknown HPV Detection

Risk of Cervical Cancer Following Incident, Persistent and History-unknown HPV Detection

Recruiting
22-70 years
Female
Phase N/A

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Overview

The goal of this register-based retrospective observational study is to understand the risk of cervical cancer following incident, persistent and history-unknown HPV detection by HPV genotype in healthy women participating in HPV-based cervical screening. The main questions it aims to answer are:

  1. Whether an incident HPV detection with certain HPV genotypes has low risk of cervical cancer in 3 to 5 years thus does not need further clinical assessment before the next screening test?
  2. How risky a persistent HPV detection is, and whether persistent detection of any high-risk HPV genotype warrant immediate clinical assessment?
  3. How risky a HPV detection is, if no previous HPV test result is available?

As being a register-based retrospective observational study, study subjects will not be asked to do any specific task for this study.

Description

This study includes all women in the study population (women at screening ages and living in the Stockholm region during 2014-2023) who had HPV positive test result(s) in the primary HPV screening. In 2014-2016, half of the screening population were randomised to primary HPV screening and the other half received cytology-based screening (NCT01511328). From 2017 onwards, all women received primary HPV screening. As data are retrieved from established registries which are already accessible to the researchers for previous and ongoing related research projects, the data collection time is almost negligible.

Eligibility

Inclusion Criteria:

  • Women living in the Great Stockholm Region in Sweden, at cervical screening ages (age 22-70 years), and having had an HPV positive result in primary HPV test during 2014-2023

Exclusion Criteria:

  • Women without valid personal identity number in the population registry

Study details
    Cervical Cancer Screening
    HPV Infection

NCT07850128

Karolinska Institutet

20 October 2026

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