Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
| HPV Testing | — | UNRESOLVED | — |
| Postmenopausal Women | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytology, p16/ki67 dual stain cytology (DS), extended genotyping, DNA methylation, viral load, | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- The number of women with CIN2+ diagnosed in either cervical biopsies or cone biopsy
- timeFrame
- at baseline ( within 3 months after index sample)
- description
- The detection of underlying CIN2 or worse
- measure
- The number of women with CIN2+ diagnosed in either cervical biopsies or cone biopsy
- timeFrame
- at follow-up ( 1.5 years after index sample)
- description
- The detection of underlying CIN2 or worse
- measure
- The number of women with CIN3+ diagnosed in either cervical biopsies or cone biopsy
- timeFrame
- at baseline ( within 3 months after index sample)
- description
- The detection of underlying CIN3 or worse
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 23 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available