Actively Recruiting

Age: 23Years - 64Years
FEMALE
Healthy Volunteers
NCT05727228

Screening Triage and Risk Stratification

Led by University of Aarhus · Updated on 2023-02-14

5000

Participants Needed

1

Research Sites

205 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

R

Randers Regional Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

* 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

Official Title

Screening Triage and Risk Stratification

Who Can Participate

Age: 23Years - 64Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • HPV-screen-positive women aged 50 to 64 years
  • Women aged 23 to 64 years undergoing test-of-cure (HPV and cytology) six months after LEEP
  • Women undergoing follow-up HPV and cytology testing 12 months after LEEP
  • Women aged 23 to 64 years with a valid cytology triage result
Not Eligible

You will not qualify if you...

  • Women who have declined to participate in research according to registry records
  • Invalid cytology and HPV results six months after LEEP
  • No residual material available for testing

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Pathology

Randers, Central Jutland, Denmark, 8930

Actively Recruiting

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Research Team

M

mette tranberg, post doc

CONTACT

L

Line Winther Gustafson, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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