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Screening Triage and Risk Stratification

RECRUITINGSponsored by University of Aarhus
Actively Recruiting
SponsorUniversity of Aarhus
Started2023-02-27
Est. completion2027-02
Eligibility
Age23 Years – 64 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05727228

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

Age: 23 Years – 64 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions4

CancerCervix CancerHPV TestingPostmenopausal Women

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