Screening Triage and Risk Stratification

Recruiting now

Conditions studied: Cervix Cancer, HPV Testing, Postmenopausal Women

In brief

* 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)

Key facts

Study ID

NCT05727228

Run by

University of Aarhus

People needed

5000

Starts

2023-02-27

Expected to finish

2027-02-01

Last updated by the study team

2023-02-14

Who can join

Age: 23 and older, up to 64. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• Department of Pathology — Randers, Central Jutland, Denmark (enrolling)

Full record on ClinicalTrials.gov

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