Screening Triage and Risk Stratification
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age23-64
SponsorUniversity of Aarhus
About this trial
* 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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Women aged 50-65 who have been tested HPV-screen positive Women aged 23-64 who undergo test-of-cure or follow-up test after LEEP
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
cytology, p16/ki67 dual stain cytology (DS), extended genotyping, DNA methylation, viral load,
Other interventionp16/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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The number of women with CIN2+ diagnosed in either cervical biopsies or cone biopsy
The detection of underlying CIN2 or worse
Time frame
at baseline ( within 3 months after index sample)2
The number of women with CIN2+ diagnosed in either cervical biopsies or cone biopsy
The detection of underlying CIN2 or worse
Time frame
at follow-up ( 1.5 years after index sample)3
The number of women with CIN3+ diagnosed in either cervical biopsies or cone biopsy
The detection of underlying CIN3 or worse
Time frame
at baseline ( within 3 months after index sample)4
The number of women with CIN3+ diagnosed in either cervical biopsies or cone biopsy
The detection of underlying CIN3 or worse
Time frame
at follow-up (1.5 years after index sample)Secondary outcomes
1
Clinical accuracy (sensitivity and specificity of each triage marker and in different combinations)
sensitivity to detect underlying CIN2+ and specificity to exclude underlying CIN2+
Time frame
at baseline (within 3 months after index sample)2
Clinical accuracy (sensitivity and specificity of each triage marker and in different combinations)
sensitivity to detect underlying CIN2+ and specificity to exclude underlying CIN2+
Time frame
at follow-up (1.5 years after index sample)3
HPV genotype distribution
We will measure the distribution of hrHPV types among these older women
Time frame
at baseline (within 3 months after index sample)4
DS positivity rate
We will measure the DS positivity rate among these older women
Time frame
at baseline (within 3 months after index sample)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Randers Regional Hospital
Collaborator
Source ClinicalTrials.gov