NCT05727228 Screening Triage and Risk Stratification
| NCT ID | NCT05727228 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Cervix Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2023-02-27 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
mette tranberg, post doc
PRINCIPAL INVESTIGATOR
Randers Regional Hospital, Denmark
Frequently Asked Questions
Who can join the NCT05727228 clinical trial?
This trial is open to female participants only, aged 23 Years or older, up to 64 Years, studying Cervix Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05727228 currently recruiting?
Yes, NCT05727228 is actively recruiting participants. Contact the research team at mettrani@rm.dk for enrollment information.
Where is the NCT05727228 trial being conducted?
This trial is being conducted at Randers, Denmark.
Who is sponsoring the NCT05727228 clinical trial?
NCT05727228 is sponsored by University of Aarhus. The principal investigator is mette tranberg, post doc at Randers Regional Hospital, Denmark. The trial plans to enroll 5,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.