An observational study in Cervical Cancer Screening and HPV Infection, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to female participants aged 22 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Karolinska Institutet · Observational
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:
As being a register-based retrospective observational study, study subjects will not be asked to do any specific task for this study.
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.
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 the primary HPV test during 2014-2023
Exclusion Criteria:
The first HPV positive result in the primary HPV test, following an HPV negative test result in the previous primary HPV test
Other: No Intervention: Observational Cohort
The HPV positive result in the primary HPV test following an HPV positive test result with the same genotype in the previous primary HPV test
Other: No Intervention: Observational Cohort
The first HPV positive result in the primary HPV test, without any primary HPV test record in the past
Other: No Intervention: Observational Cohort
All data will be retrieved retrospectively from registry data.
Diagnosis of invasive cervical cancer
Primary and invasive cervical cancer
Time frame: From HPV infection to the end of the study Dec 31st, 2024
Precancerous lesion CIN2+ (Cervical Intraepithelial Neoplasia grade 2 and above)
CIN2, CIN3, Adenocarcinoma in situ
Time frame: From HPV infection to the end of the study Dec 31st, 2024
Plan to share: Yes — IPD will be derived from the Swedish National Cervical Screening Registry and the Swedish National Quality Register for Gynaecological Cancers. Data from these two registries can be shared upon application, provided that ethical approval is obtained.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Karolinska Institutet