Patient Self-sampling of HPV to Screen for Cervical Cancer

Mayo Clinic222 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

222

Conditions

Human Papilloma Virus

Interventions

Swab kit (COBAS HPV 4800 Assay -Evalyn brush)DIAGNOSTIC_TEST

Patient self-sampling swab kit to collect a vaginal sample for HPV testing

Clinician-collection of cervical sample for HPV testingDIAGNOSTIC_TEST

Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection

Patient-collected vaginal swab HPV results compared with gold standard of clinician-collected cervical swab) to accurately detect HPV infection

Time frame: Baseline (sample was collected up to 21 days form the date of registration)

Secondary Outcomes

Patient-reported Acceptability of Using the Evalyn Brush

Assessed by survey question "Overall, how acceptable was it for you to collect the sample using the Evalyn® brush?," which was answered on a 4-point scale (completely unacceptable, unacceptable, acceptable, or completely acceptable).

Time frame: Baseline (sample was collected up to 21 days form the date of registration)

Data from ClinicalTrials.gov

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