Clinical trial · Observational
HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study
Human Papillomavirus(HPV) Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study
NCT03409471CI-TRIAL-00034557unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is a prospective observational study of human papillomavirus (HPV) testing using urine and self-collected vaginal samples for women who have atypical squamous cells of undetermined significance(ASCUS) or low grade squamous intraepithelial lesion(LSIL) on Pap test. Among women who are diagnosed with ASCUS and LSIL, HPV test is performed by collecting urine and self-collected vaginal sample in standardized condition before colposcopy, and evaluation will be performed as a primary screening test with cytology triage.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ASC-US | — | UNRESOLVED | — |
| LSIL | Low Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical Brush | Device | — | UNRESOLVED |
| Flocked Swab | Device | — | UNRESOLVED |
| HPV assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical accuracy
- timeFrame
- Within 6 months after study completion
- description
- Absolute sensitivity and specificity for finding underlying cervical intraepithelial neoplasia(CIN)2+ of HPV testing(Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit) on urine, self- and clinician-collected samples.
Secondary outcomes (2)
- measure
- Clinical accuracy
- timeFrame
- Within 6 months after study completion
- description
- Relative sensitivity and specificity of hrHPV testing on vaginal self-samples and urine sample vs clinician-collected samples.
- measure
- Analytical performance
- timeFrame
- Within 6 months after study completion
- description
- Concordance of the presence of HPV16, 18 and other high risk HPV genotyping results applied on urine, self- and clinician-collected samples
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Women with previous abnormal Pap test results (ASCUS, LSIL) * Women between the ages of 20 and 60 Exclusion Criteria: * Hysterectomised women * Women with known pregnancy * Non-consenting women * Women that are not able to understand and to sign the informed consent * Women who diagnosed and treated for cervical cancer or other malignancies * Concurrent diseases that are immunosuppressed or require the use of immune-suppressants
References
Publications (7)
- BACKGROUNDJung S, Lee B, Lee KN, Kim Y, Oh EJ. Clinical Validation of Anyplex II HPV HR Detection Test for Cervical Cancer Screening in Korea. Arch Pathol Lab Med. 2016 Mar;140(3):276-80. doi: 10.5858/arpa.2015-0117-OA. PMID 26927723
- BACKGROUNDCui M, Chan N, Liu M, Thai K, Malaczynska J, Singh I, Zhang D, Ye F. Clinical performance of Roche Cobas 4800 HPV Test. J Clin Microbiol. 2014 Jun;52(6):2210-1. doi: 10.1128/JCM.00883-14. Epub 2014 Apr 9. PMID 24719443
- BACKGROUNDStanczuk GA, Currie H, Baxter G, Foster A, Gibson L, Graham C, Cuschieri K. Cobas 4800 HPV detection in the cervical, vaginal and urine samples of women with high-grade CIN before and after treatment. J Clin Pathol. 2015 Jul;68(7):567-70. doi: 10.1136/jclinpath-2014-202851. Epub 2015 Apr 15. PMID 25878328
- BACKGROUNDConnor RJ. Sample size for testing differences in proportions for the paired-sample design. Biometrics. 1987 Mar;43(1):207-11. PMID 3567305
- BACKGROUNDStanczuk G, Baxter G, Currie H, Lawrence J, Cuschieri K, Wilson A, Arbyn M. Clinical validation of hrHPV testing on vaginal and urine self-samples in primary cervical screening (cross-sectional results from the Papillomavirus Dumfries and Galloway-PaVDaG study). BMJ Open. 2016 Apr 25;6(4):e010660. doi: 10.1136/bmjopen-2015-010660. PMID 27113237
- BACKGROUNDGuan P, Howell-Jones R, Li N, Bruni L, de Sanjose S, Franceschi S, Clifford GM. Human papillomavirus types in 115,789 HPV-positive women: a meta-analysis from cervical infection to cancer. Int J Cancer. 2012 Nov 15;131(10):2349-59. doi: 10.1002/ijc.27485. Epub 2012 Mar 20. PMID 22323075
- BACKGROUNDLandis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. PMID 843571