Back to resultsPatient Self-sampling of HPV to Screen for Cervical Cancer
Primary Purpose
Human Papilloma Virus
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Swab kit (COBAS HPV 4800 Assay -Evalyn brush)
Clinician-collection of cervical sample for HPV testing
Sponsored by
About this trial
This is an interventional screening trial for Human Papilloma Virus focused on measuring Cervical Cancer Screening
Eligibility Criteria
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.)
Sites / Locations
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Self-collected vaginal swab samples
Arm Description
Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Patient-reported acceptability and feasibility of using the Evalyn brush
Patient survey to evaluate acceptability and feasibility of using the Evalyn brush
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05600283
Brief Title
Patient Self-sampling of HPV to Screen for Cervical Cancer
Official Title
Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
Cervical Cancer Screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-collected vaginal swab samples
Arm Type
Experimental
Arm Description
Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab
Intervention Type
Diagnostic Test
Intervention Name(s)
Swab kit (COBAS HPV 4800 Assay -Evalyn brush)
Intervention Description
Patient self-sampling swab kit to collect a vaginal sample for HPV testing
Intervention Type
Diagnostic Test
Intervention Name(s)
Clinician-collection of cervical sample for HPV testing
Intervention Description
Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)
Primary Outcome Measure Information:
Title
Concordance of patient-collected and clinician-collected samples to detect HPV infection
Description
Patient-collected vaginal swab HPV results compared with gold standard of clinician-collected cervical swab) to accurately detect HPV infection
Time Frame
Anticipate 6-8 months to collect number of samples needed
Secondary Outcome Measure Information:
Title
Patient-reported acceptability and feasibility of using the Evalyn brush
Description
Patient survey to evaluate acceptability and feasibility of using the Evalyn brush
Time Frame
Patient will complete survey after using the Evalyn brush (same day)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy MacLaughlin, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Patient Self-sampling of HPV to Screen for Cervical Cancer
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