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Urinary and Vaginal HPV Testing in Cervical Cancer Screening

NCT05065853 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2021-10-04

No results posted yet for this study

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.

Conditions

  • Uterine Cervical Neoplasms

Interventions

DIAGNOSTIC_TEST

urine self-sampling group

collection of urine and vaginal samples

DIAGNOSTIC_TEST

clinician-collected cervical sample group

A clinician takes a smear from cervix according to standard routine

Sponsors & Collaborators

  • University Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital, Denmark

    collaborator UNKNOWN

  • Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium

    collaborator UNKNOWN

  • Department of Gynecology, Randers Regional Hospital, Denmark

    collaborator UNKNOWN

  • Departement of Pathology, Randers Regional Hospital , Denmark

    collaborator UNKNOWN

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Mette Tranberg, post doc · Randers Regional Hospital and Aarhus University

Eligibility

Min Age
23 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2023-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05065853 on ClinicalTrials.gov