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Clinical Trials in Denmark / NCT05727228
Recruiting Observational

Screening Triage and Risk Stratification

NCT05727228 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Observational
Started
2023-02-27
Last updated
2023-02-14

Condition(s) studied

Cervix CancerHPV TestingPostmenopausal Women

Investigational drug(s) / intervention(s)

cytology, p16/ki67 dual stain cytology (DS), extended genotyping, DNA methylation, viral load,

cytology, p16/ki67 dual stain cytology (DS), extended genotyping, DNA methylation, viral load,: p16/Ki67 dual stain cytology, extended genotyping and DNA methylation will be performed from the residual cell-pellet from the HPV-positive screening samples. If no cytology-triage testing is performed as a part of the screening algorithm, a cytology will be performed at inclusion. If any residual material is left after DS, extended genotyping and DNA methylation, it will be stores at -80 degrees for future purposes.

Study 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

Sex
FEMALE
Min age
23 Years
Max age
64 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • The number of women with CIN2+ diagnosed in either cervical biopsies or cone biopsy — at baseline ( within 3 months after index sample)
    The detection of underlying CIN2 or worse
  • The number of women with CIN2+ diagnosed in either cervical biopsies or cone biopsy — at follow-up ( 1.5 years after index sample)
    The detection of underlying CIN2 or worse
  • The number of women with CIN3+ diagnosed in either cervical biopsies or cone biopsy — at baseline ( within 3 months after index sample)
    The detection of underlying CIN3 or worse
  • The number of women with CIN3+ diagnosed in either cervical biopsies or cone biopsy — at follow-up (1.5 years after index sample)
    The detection of underlying CIN3 or worse

Trial sites (1)

FacilityCityRegionStatus
Department of Pathology Randers Central Jutland Recruiting

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Other trials for the same condition

Everolimus and/or Exercise to Prevent Bone Loss in Postmenopausal Women Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05727228 on ClinicalTrials.gov ↗ ← All trials in Denmark