Screening Triage and Risk Stratification
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age23-64
SponsorUniversity of Aarhus
About this trial
* 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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- cytology, p16/ki67 dual stain cytology (DS), extended genotyping, DNA methylation, viral load,
Treatment groups
No treatment groups listed
Sponsors and collaborators
University of Aarhus
Lead sponsor
Randers Regional Hospital
Collaborator
Source ClinicalTrials.gov