Human Papilloma VirusNCT05600283
Patient Self-sampling of HPV to Screen for Cervical Cancer
A study testing Swab kit (COBAS HPV 4800 Assay -Evalyn brush) and Clinician-collection of cervical sample for HPV testing in people with Human Papilloma Virus, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- Swab kit (COBAS HPV 4800 Assay -Evalyn brush) and Clinician-collection of cervical sample for HPV testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to 4 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening
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
- Being tested
- Swab kit (COBAS HPV 4800 Assay -Evalyn brush), Clinician-collection of cervical sample for HPV testing
- Keywords
- Cervical Cancer Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 testingDiagnostic test
Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush); Diagnostic Test: Clinician-collection of cervical sample for HPV testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (sample was collected up to 21 days form the date of registration)
Secondary outcomes (1)
Patient-reported Acceptability of Using the Evalyn Brush
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).
Measured: Baseline (sample was collected up to 21 days form the date of registration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start16 Nov 2022
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathy MacLaughlin, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600283
- Sponsor's protocol ID
- 22-008247
- Other IDs
- NCI-2022-10804
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2022
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT05600283
- Acronym / sponsor ID
- 22-008247
- Conditions
- Human Papilloma Virus
- Keywords
- Cervical Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Posted 19 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-collected vaginal swab samples | Experimental | Diagnostic Test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush), Diagnostic Test: Clinician-collection of cervical sample for HPV testingSubjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swab kit (COBAS HPV 4800 Assay -Evalyn brush)Patient self-sampling swab kit to collect a vaginal sample for HPV testing | Diagnostic test | Self-collected vaginal swab samples |
| Clinician-collection of cervical sample for HPV testingSpeculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush) | Diagnostic test | Self-collected vaginal swab samples |
Primary outcome
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
1 secondary outcome
Patient-reported Acceptability of Using the Evalyn Brush
Time frame: Baseline (sample was collected up to 21 days form the date of registration)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy MacLaughlin, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swab kit (COBAS HPV 4800 Assay -Evalyn brush) and Clinician-collection of cervical sample for HPV testing in people with Human Papilloma Virus, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.