Urinary and Vaginal HPV Testing in Cervical Cancer Screening

NCT05065853 | Unknown

• 1 other identifier: 2703
• Study Type: observational
• Target: 330
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

HPV DNA tests, self-collection, cervical cancer screening

Outcome Measures

Primary Outcomes (2)

• 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+

  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+

  at baseline

Interventions

urine self-sampling group DIAGNOSTIC_TEST

collection of urine and vaginal samples

Also known as: vaginal self-sampling group

clinician-collected cervical sample group DIAGNOSTIC_TEST

A clinician takes a smear from cervix according to standard routine

Eligibility Criteria

• Age: 23 Years - 64 Years
• Gender Eligibility Details: Only female can be diagnosed with cervical cancer or its precancer lesion, thus only women are candidates for inclusion.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women aged 23-64 years referred for colposcopy and cervical biopsies due to abnormal cervical cancer screening result or referred for cervical excision due to treatment of CIN2+

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• University Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital, Denmark: collaborator
• Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Belgium: collaborator
• Department of Gynecology, Randers Regional Hospital, Denmark: collaborator
• Departement of Pathology, Randers Regional Hospital , Denmark: collaborator

Related Publications (1)

• Tranberg M, Van Keer S, Jensen JS, Norgaard P, Gustafson LW, Hammer A, Bor P, Binderup KO, Blach C, Vorsters A. High-risk human papillomavirus testing in first-void urine as a novel and non-invasive cervical cancer screening modality-a Danish diagnostic test accuracy study. BMC Med. 2025 Jun 2;23(1):327. doi: 10.1186/s12916-025-04149-0.

  PMID: 40457337 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

First-void urine samples Vaginal self-samples Clinician-collected cervical samples Cervical biopsy Cone biopsy

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mette Tranberg, post doc

  Randers Regional Hospital and Aarhus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mette tranberg, post doc

CONTACT

+45 7842 0264; mettrani@rm.dk

Berit Andersen, prof. MD

CONTACT

+45 7842 0171; berand@rm.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post doc, PhD, MScH, biomedical laboratory scientist

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 4, 2021
• Study Start: October 18, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share