Patient Self-sampling of HPV to Screen for Cervical Cancer

Not Applicable

Completed

• Conditions: Human Papilloma Virus
• Interventions: Diagnostic Test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush); Diagnostic Test: Clinician-collection of cervical sample for HPV testing

• Registration Number: NCT05600283
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Study Start: 2022-11-16
• Primary Completion: 2024-06-04
• Study Completion: 2024-06-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 223

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).

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self-collected vaginal swab samples	Clinician-collection of cervical sample for HPV testing	Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab
Self-collected vaginal swab samples	Swab kit (COBAS HPV 4800 Assay -Evalyn brush)	Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab

Primary Outcome Measures

Name	Time	Method
Concordance of patient-collected and clinician-collected samples to detect HPV infection	Anticipate 6-8 months to collect number of samples needed	Patient-collected vaginal swab HPV results compared with gold standard of clinician-collected cervical swab) to accurately detect HPV infection

Secondary Outcome Measures

Name	Time	Method
Patient-reported acceptability and feasibility of using the Evalyn brush	Patient will complete survey after using the Evalyn brush (same day)	Patient survey to evaluate acceptability and feasibility of using the Evalyn brush

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States