Follow-up of Cell Changes in the Cervix
- Conditions
- Cancer of Cervix
- Interventions
- Diagnostic Test: HPV genotyping
- Registration Number
- NCT05709730
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
The purpose of the study is to follow up on cell changes detected in the cervical cancer screening program, to investigate whether they are handled with adequate quality.
- Detailed Description
The aim of the study is to clarify whether follow-up of cell changes is carried out with sufficiently good quality. It is nationally recommended to perform an HPV test on mild cell changes and only refer to clinical follow-up if you are HPV positive. Descriptive statistics on HPV-testing and follow-up of quality are not available today. If HPV testing has not already been performed, archived samples with glandular cell changes will be HPV-analyzed in Cobas 4800 HPV-polymerase chain reaction (PCR), which shows data on the presence of HPV and Luminex-PCR, which shows which HPV types the samples have. Women with low-grade squamous cell changes (ASCUS and CIN1) with simultaneous HPV analysis will be followed up with data from the Swedish National Cervical Screening Registry (NKCx) from the last ten years. A register linkage with data from NKCx and the National Cancer Registry at the National Board of Health and Welfare will be carried out to determine which women have developed gynecological cancer, cervical cancer and/or pre-cancer (cancer in situ). A follow-up review of reported original cytological (cell samples) and histological (tissue samples) diagnoses will be performed by cytodiagnostics and cytopathologists, to verify the correct diagnosis.
Statistics on collection of non-organized cell samples after a partial negative sample where follow-up is not recommended are produced in aggregated form in the form of an extract from NKCx
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 885
- women with an AGC diagnosis between February 17, 2014 and December 31, 2018
- 23-80 years old
- resident of the Stockholm-Gotland region of Sweden
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women aged 26-80 with atypical glandular cell (AGC) cytology result HPV genotyping Women in the capital region of Sweden with AGC, a concomitant human papillomavirus (HPV) analysis, and a histopathology.
- Primary Outcome Measures
Name Time Method cervical intraepithelial neoplasia 3 (CIN3+) 2014-2018 Risk for developing CIN3+ or worse depending on HPV type
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden