Patient Self-sampling of HPV to Screen for Cervical Cancer
Completed · Not applicable
Conditions studied: Human Papilloma Virus
In brief
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.
Key facts
- Study ID
- NCT05600283
- Run by
- Mayo Clinic
- People needed
- 222
- Starts
- 2022-11-16
- Expected to finish
- 2024-06-04
- Last updated by the study team
- 2026-01-06
Who can join
Age: 25 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.)
Where it is running
- Mayo Clinic Minnesota — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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