Patient Self-sampling of HPV to Screen for Cervical Cancer

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05600283
• Other study ID #: 22-008247
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 125
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Human Papilloma Virus
• Papilloma
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• Swab kit (COBAS HPV 4800 Assay -Evalyn brush)
Patient self-sampling swab kit to collect a vaginal sample for HPV testing
• Clinician-collection of cervical sample for HPV testing
Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)

External Links

•   Mayo Clinic Clinical Trials