Screening Triage and Risk Stratification (NCT05727228) | Clinical Trial Compass
RecruitingNot Applicable
Screening Triage and Risk Stratification
Denmark5,000 participantsStarted 2023-02-27
Plain-language 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)
Who can participate
Age range
23 Years – 64 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of women with CIN2+ diagnosed in either cervical biopsies or cone biopsy
Timeframe: at baseline ( within 3 months after index sample)
2
The number of women with CIN2+ diagnosed in either cervical biopsies or cone biopsy
Timeframe: at follow-up ( 1.5 years after index sample)
3
The number of women with CIN3+ diagnosed in either cervical biopsies or cone biopsy
Timeframe: at baseline ( within 3 months after index sample)
4
The number of women with CIN3+ diagnosed in either cervical biopsies or cone biopsy
Timeframe: at follow-up (1.5 years after index sample)