Evaluating Triage Methods for HPV-Positive Women
Official title: Improving Screening Triage in Older Postmenopausal HPV-screen-positive Women Aged 50-64 and Risk-stratification of Women Aged 23-64 After Excision
Run by University of Aarhus · NCT05727228 · Data updated 2026-11-12
This study is testing different ways to check the risk of serious cervical changes in HPV-positive women aged 50-64 to see which method works best and helps avoid unnecessary doctor visits.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 23 Years to 64 Years |
| Sex | Women only |
| Enrollment | 5000 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Randers, Central Jutland) |
| Status | Recruiting |
| Started | February 27, 2023 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | February 14, 2023 |
| Trial ID | NCT05727228 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are post-menopausal women aged 50-64 who are HPV-screen-positive and women aged 23-64 undergoing follow-up after cervical excision.
✕Probably not a fit
Patients who have previously opted out of research participation or have invalid cytology and HPV results will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates various triage markers, including cytology, p16/Ki67 dual stain cytology, DNA methylation, and viral load, to assess their effectiveness in predicting the risk of developing cervical intraepithelial neoplasia (CIN2+) in post-menopausal women aged 50-64 who test positive for HPV. The research is divided into two work packages: the first focuses on women in organized screening programs, while the second examines long-term risks of residual or recurrent CIN2+ lesions in women aged 23-64 after cervical excision. By comparing these methods, the study aims to improve the accuracy of risk stratification and reduce unnecessary referrals for colposcopy.
Why it matters
Potential benefit: If successful, this study could lead to more accurate screening and triage methods for HPV-positive women, potentially reducing the incidence of cervical cancer.
How similar studies have gone: Previous studies have shown promising results with similar triage approaches, indicating potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Department of Pathology
Randers, Central Jutland, Denmark Recruiting
Study contacts
- Principal investigator: mette tranberg, post doc — Randers Regional Hospital, Denmark
- Study coordinator: mette tranberg, post doc
- Email: mettrani@rm.dk
- Phone: 40113676
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.