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OpenTrials
Completed

NCT Number: NCT05600283

Patient Self-sampling of HPV to Screen for Cervical Cancer

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.

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Key information

Conditions

Human Papilloma Virus

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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 testing

Diagnostic Test

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

Primary outcomes

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

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

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

Secondary outcomes

  1. Patient-reported Acceptability of Using the Evalyn Brush

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

    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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2022
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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