Clinical trial · Observational
Urinary and Vaginal HPV Testing in Cervical Cancer Screening
Urinary and Vaginal HPV Testing as a Novel Cervical Cancer Screening Tool: a Diagnostic Test Accuracy Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clinician-collected cervical sample group | Diagnostic Test | — | UNRESOLVED |
| urine self-sampling group | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- relative sensitivity and specificity of urinary sampling
- timeFrame
- at baseline
- description
- 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+
- measure
- relative sensitivity and specificity of vaginal self-sampling
- timeFrame
- at baseline
- description
- 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+
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 23 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDTranberg M, Van Keer S, Hesselink AT, Norgaard P, Brondum R, Wu C, Gustafson LW, Hammer A, Bor P, Binderup KO, Blach C, Vorsters A, Steenbergen R. Evaluating DNA methylation markers and extended HPV genotyping in first-void urine for detecting high-grade cervical lesions in HPV-positive women: a cross-sectional study. BMC Med. 2026 Apr 10;24(1):308. doi: 10.1186/s12916-026-04837-5. PMID 41957618
- DERIVEDTranberg 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