Patient Self-sampling of HPV to Screen for Cervical Cancer

Mayo Clinic

Status: Completed

Conditions: Human Papilloma Virus

Treatments: Diagnostic Test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush); Diagnostic Test: Clinician-collection of cervical sample for HPV testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05600283

22-008247

NCI-2022-10804 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 222 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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222 participants in 1 patient group

Self-collected vaginal swab samples

Experimental group

Description:

Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab

Treatment:

Diagnostic Test: Clinician-collection of cervical sample for HPV testing

Diagnostic Test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush)