ClinicalTrialsFinder
RecruitingNCT05727228

Screening Triage and Risk Stratification

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

Sponsor

University of Aarhus

Enrollment

5,000 participants

Start Date

Feb 27, 2023

Study Type

OBSERVATIONAL

Conditions

Cervix CancerHPV TestingPostmenopausal Women

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: FEMALEMin Age: 23 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new way to triage and manage women who test positive for HPV (the virus linked to cervical cancer) in Denmark's screening program. Researchers want to find better tools to decide who needs more urgent follow-up after HPV-positive results or after treatment. **You may be eligible if...** - You are a woman aged 50–64 who tested HPV-positive in a routine screen, OR - You are aged 23–64 and had a procedure (LEEP) to treat cervical changes and are due for a follow-up HPV test - You have a valid cytology (cell test) result **You may NOT be eligible if...** - You have opted out of the cancer screening registry - You do not meet the age or clinical criteria above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERcytology, 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.

Locations(1)

Department of Pathology

Randers, Central Jutland, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05727228

Related Trials

Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health

NCT069532321 location

Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV

NCT074283301 location

Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda

NCT072763601 location

Late Radiation Toxicities in Cervical and Endometrial Cancer: A Postoperative IMRT/Brachytherapy Study

NCT074356231 location

Development of Clinically High Efficient Platforms for Individualised Treatment of Cervix Cancer

NCT051022401 location