Testing Methods to Judge Cervical Changes in Women Aged 50 to 64
Studies tests that check cervical samples to predict later precancerous changes in women.
Plain-language title generated from the registry record
Registry title: Screening Triage and Risk Stratification
Key facts
- Where
- Randers, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 23 and 64 years old?
Source: NCT05727228, who can take part
Where in Denmark
- Department of PathologyRanders, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT05727228
- Record updated
- 14 February 2023
- Original description
* 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)Read full original descriptionShow less
Improving Screening Triage in Older Postmenopausal HPV-screen-positive Women Aged 50-64 and Risk-stratification of Women Aged 23-64 After Excision
* 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)
Inclusion: 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: 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.