Improving Screening Triage in Older Postmenopausal HPV-screen-positive Women Aged 50-64 and Risk-stratification of Women Aged 23-64 After Excision

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 23
Maximum Age: 64
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Denmark
Department of Pathology
RECRUITING
Randers
Contact Information
Primary
mette tranberg, post doc
mettrani@rm.dk
40113676
Backup
Line Winther Gustafson, MD
Line.Winther@skejby.rm.dk
+4578420264
Time Frame
Start Date: 2023-02-27
Estimated Completion Date: 2027-02
Participants
Target number of participants: 5000
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus
Collaborators: Randers Regional Hospital

This content was sourced from clinicaltrials.gov