Patient Self-sampling of HPV to Screen for Cervical Cancer

Overview

About this study

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. Its secondary aim is to assess the patient perspective on acceptability and feasibility of a self-sampling approach to cervical cancer screening through a survey of study enrollees. The third aim will assess the stability testing component to analyze concordance of multiple self-collected Evalyn brush HPV results within the same study subject.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Females ≥ 25 and ≤ 60 years of age.
  • 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.)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/18/24. Questions regarding updates should be directed to the study team contact

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathy MacLaughlin, M.D.

Closed for enrollment

Contact information:

Kathy MacLaughlin M.D.

(507) 284-6915

MacLaughlin.Kathy@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20539802

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