Clinical trial · Observational
Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection
Clinical Study to Compare the Performance of Self-collected Vaginal Samples Transported Dry to Those Transported Wet for Detection of hrHPV DNA.
NCT06213051CI-TRIAL-00079208HPVsuspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Why stopped (as posted): funding issues
Summary
Brief summary (as posted)
This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA LBC as the reference standard.
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 |
|---|---|---|---|
| • COPAN Self-collection FLOQSwabs® (COPAN, Italy) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort of sexually active adult females with an abnormal cervical cancer screening result.
- description
- Multi-center, prospective, paired, comparative diagnostic accuracy study To compare the performance of self-collected vaginal samples transported dry to those transported wet for detection of hrHPV DNA. Interventions: COPAN floq swab transported wet and dry evaluated on Roche COBAS and Cepheid Xpert HPV tests
- interventionNames
- Device: • COPAN Self-collection FLOQSwabs® (COPAN, Italy)
Primary outcomes (1)
- measure
- To compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR on health care provider-collected cervical samples as the reference standard.
- timeFrame
- 6 Months
- description
- Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR as the reference standard.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion criteria for participants screened and enrolled consecutively as they present at the clinical study site: * Sexually active adult females ≥30 years of age (≥25 years of age if HIV+) presenting for treatment at a facility with an abnormal cervical cancer screening result (abnormal cytology, visual inspection with acetic acid and/or colposcopy) * Able to understand scope of study * Able to provide written informed consent * Willing to provide all necessary samples Exclusion Criteria: * Vaccinated for HPV * Pregnancy * Patient not willing or unable to provide the all three swab samples (self-collected dry and wet and HCW collected cervical swabs)
References
Publications (0)
Data not yet available
No reference posted for this study.