NCT05600283Completed
Patient Self-sampling of HPV to Screen for Cervical Cancer
Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 222 (actual)
- First submitted
- 26 Oct 2022
- Start date
- Nov 2022
- Primary completion date
- Jun 2024
- Lead sponsor
- Mayo Clinic
- Diseases
- Cervical cancer
- NCT number
- NCT05600283
What you commit to
- Study type: Interventional
- Participants enrolled: 222
- From Nov 2022 to the primary completion date, Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.)
Other illness
- Excluded if no cervix (history of total hysterectomy).
- Excluded if moderate to heavy vaginal bleeding on the day of the visit.
Other
- Excluded if self-reported as currently menstruating, pregnant, or within 3 months following pregnancy.
- 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).
Who the study is looking for
- 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).
Age in the registry: 25 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Minnesota Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.