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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-10804 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swab kit (COBAS HPV 4800 Assay -Evalyn brush) | Diagnostic Test | Patient self-sampling swab kit to collect a vaginal sample for HPV testing |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (sample was collected up to 21 days form the date of registration) |
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Inclusion Criteria:
Exclusion Criteria:
(Vaginal contraceptives, condoms and water-based lubricants can be used as normal.)
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| Name | Affiliation | Role |
|---|---|---|
| Kathy MacLaughlin, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Group 1: eligible participants enrolled = 89 (98 participants initially deemed eligible; 9 participants declined to participate) Group 2: eligible participants enrolled = 133 (207 participants initially deemed eligible; 74 declined to participate)
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Self-collected Vaginal Swab Samples at Clinic | Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab 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) |
| FG001 | Group 2: Self-collected Vaginal Swab Samples at Home | Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Self-collected Vaginal Swab Samples at Clinic | Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab 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) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | Total Percentage Agreement | Baseline (sample was collected up to 21 days form the date of registration) |
|
Baseline (at the time of swab collection). Participants collected swab samples up to 21 days from the time of enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Self-collected Vaginal Swab Samples at Clinic | Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant inserted self-collection device with cap on (did not remove cap) | Product Issues | Non-systematic Assessment | No harm resulted from events. The study team thereafter highlighted the instruction sheet where it tells the subject to remove the cap. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathy MacLaughlin | Mayo Clinic | 507-266-4648 | maclaughlin.kathy@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2023 | Jul 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2025 | Jul 24, 2025 | ICF_001.pdf |
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| 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) |
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| Missing Clinician Collection |
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| Screen Failure |
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| Sample Lost in Transit |
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| BG001 | Group 2: Self-collected Vaginal Swab Samples at Home | Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Group 2: Self-collected Vaginal Swab Samples at Home | Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab 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) |
|
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| Secondary | 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). | Survey results are reported for all participants who completed vaginal self-collection and returned the survey, even if the self-collection sample was deemed invalid or clinician sample was not received. | Posted | Number | Participants | Baseline (sample was collected up to 21 days form the date of registration) |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 2 |
| 81 |
| EG001 | Group 2: Self-collected Vaginal Swab Samples at Home | Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab 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) | 0 | 127 | 0 | 127 | 1 | 127 |
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| Device damaged during mailing to patient | Product Issues | Non-systematic Assessment | Participant unable to rotate vaginal brush, even with additional pressure. Device broke as it was withdrawn. Manufacturer verified no defect with product at shipment. Following event, devices were mailed in boxes instead of padded envelopes. |
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| Acceptable |
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| Completely acceptable |
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