Patient Self-sampling of HPV to Screen for Cervical Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Human Papilloma Virus

Intervention / Treatment
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* Diagnostic Test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush)
* Diagnostic Test: Clinician-collection of cervical sample for HPV testing


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-collected vaginal swab samples<br>Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab | Diagnostic Test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush)<br>* Patient self-sampling swab kit to collect a vaginal sample for HPV testing<br>Diagnostic Test: Clinician-collection of cervical sample for HPV testing<br>* Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Anticipate 6-8 months to collect number of samples needed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported acceptability and feasibility of using the Evalyn brush | Patient survey to evaluate acceptability and feasibility of using the Evalyn brush | Patient will complete survey after using the Evalyn brush (same day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Cancer Screening