Clinical trial · Interventional
Patient Self-sampling of HPV to Screen for Cervical Cancer
Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening
NCT05600283CI-TRIAL-00100222completedN/AResults postedClinicalTrials.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 purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Researchers will compare the laboratory results of self-collected vaginal swab samples to usual healthcare provider-collected cervical swab samples to determine the laboratory HPV testing accuracy of the self-collection swab.
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 Papilloma Virus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinician-collection of cervical sample for HPV testing | Diagnostic Test | — | UNRESOLVED |
| Swab kit (COBAS HPV 4800 Assay -Evalyn brush) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Self-collected vaginal swab samples
- description
- Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab
- interventionNames
- Diagnostic Test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush)
- Diagnostic Test: Clinician-collection of cervical sample for HPV testing
Primary outcomes (1)
- measure
- Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection
- timeFrame
- Baseline (sample was collected up to 21 days form the date of registration)
- description
- Patient-collected vaginal swab HPV results compared with gold standard of clinician-collected cervical swab) to accurately detect HPV infection
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Appointment at Mayo Clinic Rochester in Gynecology Colposcopy Clinic or ICS (integrated community specialty) Colposcopy Clinic (will always include a speculum exam). * Appointment at Mayo Clinic Rochester in Gynecology Clinic for indication that will already include a speculum exam (e.g., cervical cancer screening or IUD insertion). Exclusion Criteria: * Excluded if self-reported as currently menstruating, pregnant, or within 3 months following pregnancy. * Excluded if no cervix (history of total hysterectomy). * Excluded if moderate to heavy vaginal bleeding on the day of the visit. * Excluded if reason for visit in Gynecology Clinic is abnormal vaginal discharge. * Exclude patients who are on Gynecology Colposcopy Clinic for LEEP (loop electrosurgical excision procedure). * Exclude if any use of over-the-counter or prescription vaginal cream for vaginal infection or prescription vaginal estrogen cream for at least two days before using the Evalyn Brush. (Vaginal contraceptives, condoms and water-based lubricants can be used as normal.)
References
Publications (0)
Data not yet available
No reference posted for this study.