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Enrolling By Invitation NCT05600283

Patient Self-sampling of HPV to Screen for Cervical Cancer

Conditions: Human Papilloma Virus

Sex: Female
Ages: 25 Years – 65 Years
Phase: NA
Enrollment: 125
Sponsor: Mayo Clinic

Location: United States

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.)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05600283). StuddyBuddy aggregates publicly available trial information.