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Screening Triage and Risk Stratification
Sponsor: University of Aarhus
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)
Official title: Improving Screening Triage in Older Postmenopausal HPV-screen-positive Women Aged 50-64 and Risk-stratification of Women Aged 23-64 After Excision
Key Details
Gender
FEMALE
Age Range
23 Years - 64 Years
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2023-02-27
Completion Date
2027-02
Last Updated
2023-02-14
Healthy Volunteers
Yes
Interventions
cytology, p16/ki67 dual stain cytology (DS), extended genotyping, DNA methylation, viral load,
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)
Department of Pathology
Randers, Central Jutland, Denmark