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Urinary and Vaginal HPV Testing in Cervical Cancer Screening

NCT05065853UNKNOWNOBSERVATIONAL

Summary

Cervical cancer, caused by high-risk human papillomavirus (HPV) infection, poses a problem worldwide as it is the fourth most common female cancer. Fifty percent of all invasive cervical cancers occur among the 25% not attending cervical cancer screening. To reach these women, this project will contribute to the development of a novel and accurate urinary and vaginal screening tool, which allows women to collect the screening samples at home. This project tests the hypotheses: 1) urinary HPV testing is non-inferior to HPV testing on clinician-collected cervical samples for detection of high-grade cervical pre-cancer, 2) Vaginal HPV testing is non-inferior to HPV testing on clinician-collected cervical samples for detection of high-grade cervical pre-cancer and 3) DNA methylation testing is suitable as a colposcopy triage test among women with HPV-positive urine and/or vaginal samples to prevent unnecessary colposcopies and overtreatment of women without clinically meaningful HPV infections. If confirmed, urinary and vaginal HPV testing could revolutionize todays screening programs and keep Denmark at the forefront of cervical cancer prevention.

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

330

Start Date

2021-10-18

Completion Date

2023-12-31

Study Type

OBSERVATIONAL

Official Title

Urinary and Vaginal HPV Testing as a Novel Cervical Cancer Screening Tool: a Diagnostic Test Accuracy Study

Interventions

urine self-sampling groupclinician-collected cervical sample group

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

23 Years – 64 Years

Sex

FEMALE

Inclusion Criteria:

* Females
* Aged 23-64 years
* Referred for colposcopy and cervical biopsies or referred for cervical excision

Exclusion Criteria:

* younger than 23 years
* older than 64 years
* not provided informed conte

Outcome Measures

Primary Outcomes

relative sensitivity and specificity of urinary sampling

The primary endpoint will be the relative sensitivity and specificity of HPV testing in first-void urine versus clinician-collected cervical samples to detect CIN2+

Time frame: at baseline

relative sensitivity and specificity of vaginal self-sampling

The primary endpoint will be the relative sensitivity and specificity of HPV testing in vaginal self-samples versus clinician-collected cervical samples to detect CIN2+

Time frame: at baseline

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

Linked Investigators

Mette Tranberg

I am an intervention and epidemiological researcher with powerful laboratory skills enabling me to conduct large-scale population-based intervention studies combining the worlds of epidemiology, cervical cancer screening, and diagnostics into one.