Clinical trial · Observational
Clinical Correlation Between Self-collected and Physician-collected HPV Screening Kits
NCT05679141CI-TRIAL-00076518completedClinicalTrials.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)
The objective of this study is to validate the of the Evalyn®Brush via self-collection to the standard clinician-collected technique using the BD SurePath™ collection vial and Rovers CombiBrush for detection of Human Papillomavirus (HPV). This study will validate the sensitivity and specificity of the Evalyn Brush with the future goal of making this testing approach available for self-collection in the future.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Clinical Correlation - Positives
- timeFrame
- Through study completion, an average of 12 weeks
- description
- Samples collected via self-collection correlate \>95% to those clinician-collected
- measure
- Clinical Correlation - Negatives
- timeFrame
- Through study completion, an average of 12 weeks
- description
- Samples collected via self-collection correlate \>95% to those clinician-collected
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Participant visiting the study site for a potential OB/GYN purpose * Participant \>= 21 years of age * Participant has a cervix Exclusion Criteria: * Currently menstruating * Currently pregnant or within 3 months following pregnancy * Utilized vaginal products within past 48 hrs. * Experiencing any of following symptoms: Pain in lower abdomen Fever Unusual or heavy vaginal discharge Pain / bleeding when having intercourse Painful or frequent urination
References
Publications (0)
Data not yet available
No reference posted for this study.