Clinical trial · Interventional
Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs
NCT01316120CI-TRIAL-00005978HPVDryunknownN/AClinicalTrials.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)
Human papillomavirus (HPV) assays are likely to be used in cervical cancer screening. Our objective is to simplify the method of collection of female genital tract specimens by determining if vaginal dry swabs are as accurate as the standard transport medium for HPV diagnosis.
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 |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compare different self-obtained specimen for HPV identification | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HPV Dry first
- description
- Randomization will determine the sequence of the two tests, avoiding potential bias that may advantage the "first" test. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic tests
- interventionNames
- Other: Compare different self-obtained specimen for HPV identification
- type
- EXPERIMENTAL
- label
- HPV standard transport medium
- description
- Randomization will determine the sequence of the two tests, avoiding potential bias that may advantage the "first" test. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic tests
- interventionNames
- Other: Compare different self-obtained specimen for HPV identification
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 20 years or older, * First consultation in our colposcopy unit, * Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF). Exclusion Criteria: * Previous hysterectomy, * Pregnant, * Virgin, * Not able to comply with the protocol study.
References
Publications (1)
- DERIVEDEperon I, Vassilakos P, Navarria I, Menoud PA, Gauthier A, Pache JC, Boulvain M, Untiet S, Petignat P. Randomized comparison of vaginal self-sampling by standard vs. dry swabs for human papillomavirus testing. BMC Cancer. 2013 Jul 22;13:353. doi: 10.1186/1471-2407-13-353. PMID 23875668