Screening Triage and Risk Stratification

Sex: Female

Ages: 23 Years – 64 Years

Healthy volunteers: 1

Enrollment: 5000

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)

Eligibility Criteria

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 LEEPA valid cytology-triage result (aged 23-64)Exclusion Criteria:Listed in the registry as a person who have rejected to participate in researchInvalid cytology and HPV result six months after LEEPNo residual material available

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05727228). StuddyBuddy aggregates publicly available trial information.