Screening Triage and Risk Stratification
Improving Screening Triage in Older Postmenopausal HPV-screen-positive Women Aged 50-64 and Risk-stratification of Women Aged 23-64 After Excision
University of Aarhus
5,000 participants
Feb 27, 2023
OBSERVATIONAL
Conditions
Summary
* To investigate the performance of cytology, extended genotyping, p16/Ki67 dual stain cytology, DNA methylation and viral load as triage markers in post-menopausal HPV-screen-positive women aged 50-64 years in the organized screening program to predict the risk of developing CIN2+. (work package 1) * To investigate the performance of cytology, extended genotyping, p16/Ki67 dual stain cytology, DNA methylation and viral load six months after cervical excision to predict the long-term risk of residual/recurrent CIN2+ lesions among women aged 23-64 (work-package 2)
Eligibility
Inclusion Criteria4
- HPV-screen-positive (aged 50-64)
- Women who undergo test-of-cure (i.e. HPV and cytology) six months after LEEP in Central Denmark Region (aged 23-64)
- Women who undergo follow-up test (i.e. HPV and cytology) 12 months after LEEP
- A valid cytology-triage result (aged 23-64)
Exclusion Criteria3
- Listed in the registry as a person who have rejected to participate in research
- Invalid cytology and HPV result six months after LEEP
- No residual material available
Interventions
p16/Ki67 dual stain cytology, extended genotyping and DNA methylation will be performed from the residual cell-pellet from the HPV-positive screening samples. If no cytology-triage testing is performed as a part of the screening algorithm, a cytology will be performed at inclusion. If any residual material is left after DS, extended genotyping and DNA methylation, it will be stores at -80 degrees for future purposes.
Locations(1)
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NCT05727228