N/A
N=222
Patient Self-sampling of HPV to Screen for Cervical Cancer
Human Papilloma Virus
Bottom Line
View on ClinicalTrials.gov: NCT05600283 ↗Enrolled (actual)
222
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection — 98; 94; 99; 95 Total Percentage Agreement
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Swab kit (COBAS HPV 4800 Assay -Evalyn brush) (Diagnostic_test); Clinician-collection of cervical sample for HPV testing (Diagnostic_test)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection |
98; 94; 99; 95; 86; 89 | — |
| SECONDARY Patient-reported Acceptability of Using the Evalyn Brush |
0; 0; 0; 1; 15; 37 | — |
Summary
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.
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT05600283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.