NCT05727228Recruiting
Screening Triage and Risk Stratification
Improving Screening Triage in Older Postmenopausal HPV-screen-positive Women Aged 50-64 and Risk-stratification of Women Aged 23-64 After Excision
Source: ClinicalTrials.gov · Last updated 14 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
* 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)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 16 Jan 2023
- Start date
- 27 Feb 2023
- Primary completion date
- Feb 2027
- Lead sponsor
- University of Aarhus
- Diseases
- Cervical cancer
- NCT number
- NCT05727228
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 27 Feb 2023 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 23 years to 64 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Pathology Coordinator of this site? Confirm its status | Randers | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.