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Screening Triage and Risk Stratification

Recruitingn/aAges 23 Years - 64 YearsFemaleUniversity of Aarhus
NCT05727228 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

* 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)

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • cytology, p16/ki67 dual stain cytology (DS), extended genotyping, DNA methylation, viral load,
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Where

1 site
Department of Pathology
Randers, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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