NCT05600283

Patient Self-sampling of HPV to Screen for Cervical Cancer

Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Human Papilloma Virus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Swab kit (COBAS HPV 4800 Assay -Evalyn brush)	Patient self-sampling swab kit to collect a vaginal sample for HPV testing
DIAGNOSTIC_TEST	Clinician-collection of cervical sample for HPV testing	Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)

Timeline

• Start date: 2022-11-16
• Primary completion: 2024-06-04
• Completion: 2024-06-04
• First posted: 2022-10-31
• Last updated: 2026-01-06
• Results posted: 2025-09-19

Locations

1 site across 1 country: United States