Patient Self-sampling of HPV to Screen for Cervical Cancer

NCT05600283 | Completed Results

• 2 other identifiers: 22-008247NCI-2022-10804
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papilloma Virus

Keywords

Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (1)

• Patient-reported Acceptability of Using the Evalyn Brush

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

Study Arms (1)

Self-collected vaginal swab samples

EXPERIMENTAL

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); Diagnostic Test: Clinician-collection of cervical sample for HPV testing

Interventions

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

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

Self-collected vaginal swab samples

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)

Self-collected vaginal swab samples

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Dr. Kathy MacLaughlin
• Organization: Mayo Clinic

maclaughlin.kathy@mayo.edu

507-266-4648

Study Officials

• Kathy MacLaughlin, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: November 16, 2022
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: January 6, 2026
• Results First Posted: September 19, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)