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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04139 | Registry Identifier | CTRP | |
| GYNCVX0005 | Other Identifier | Stanford OnCore |
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The purpose of this study is to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA via self-collected menstrual blood in a smart menstrual pad. In other words, can the investigators detect the high risk strains of the human papilloma virus (HPV) that are associated with cervical cancer in self-collected menstrual blood, as an alternative to collecting vaginal swabs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk HPV Positive Cohort | This group of women have tested positive for HR-HPV at annual cervical cancer screening and have been invited to participate in the study. They will be asked to use a menstrual pad we provide that collects a sample of their menstrual blood (strip). The strip will be mailed back to us for analysis (Menstrual Blood Analysis). These women will also be asked to conduct a self-swab vaginally to be sent back to us for analysis. These women will return 6-months after their positive HR-HPV for standard of care testing. All results of the standard of care tests, menstrual blood tests, and self-swab tests will be compared. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menstrual Blood Analysis (Menstrual Blood Analysis) | Diagnostic Test | We will be testing women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA via self-collected menstrual blood from a menstrual pad. |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen | The clinician collected a vaginal swab to detect HPV, then participants used a modified menstrual pad to self-collect a sample within 2 months of the clinician collected swab (may have happened at up to 4 mo.). Participants may have had prior history of dysplasia or HPV positivity, or were from general population receiving regular check-up. Agreement between the clinician-collected swabs and participant-collected menstrual samples was assessed in:
| 2-4-months after initial clinician collected samples were obtained and sent for HR-HPV DNA or HPV E6/E7 mRNA |
| Agreement Between Self-collected Vaginal Swabs vs Clinician-collected Cervical Specimens With High-risk HPV-Positive Results | 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Preferred the Modified Menstrual Pad to Clinician-collected Cervical Specimens | 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA | |
| Number of Participants Who Opted Out of Self-swab Due to Discomfort With the Procedure |
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Inclusion Criteria:
There will be two study groups: 1) menstruating women over the age of 18 who have previous history of HR-HPV in the last 18 months and 2) menstruating women over the age of 18 who do not have a previous history of HR-HPV.
Exclusion Criteria:
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Menstruating women over the age of 18.
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| Name | Affiliation | Role |
|---|---|---|
| Paul D Blumenthal, MD, MPH | Stanford University, Department of OB/GYN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Gynecology Clinic | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35926207 | Result | Naseri S, Young S, Cruz G, Blumenthal PD. Screening for High-Risk Human Papillomavirus Using Passive, Self-Collected Menstrual Blood. Obstet Gynecol. 2022 Sep 1;140(3):470-476. doi: 10.1097/AOG.0000000000004904. Epub 2022 Aug 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Risk HPV Positive Cohort | Testing of women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA self-collected via menstrual pad. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | High Risk HPV Positive Cohort | Testing of women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA self-collected via menstrual pad. |
| 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 | Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen | The clinician collected a vaginal swab to detect HPV, then participants used a modified menstrual pad to self-collect a sample within 2 months of the clinician collected swab (may have happened at up to 4 mo.). Participants may have had prior history of dysplasia or HPV positivity, or were from general population receiving regular check-up. Agreement between the clinician-collected swabs and participant-collected menstrual samples was assessed in:
| Participants with specimens meeting clinical criteria for each analysis category | Posted | Number | 95% Confidence Interval | percentage of agreement | 2-4-months after initial clinician collected samples were obtained and sent for HR-HPV DNA or HPV E6/E7 mRNA |
On average up to 120 days
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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 | High Risk HPV Positive Cohort | Testing of women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA self-collected via menstrual pad. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Blumenthal, MD | Stanford University | (650) 725-6035 | gynresearch@stanford.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 | Mar 17, 2020 | Oct 4, 2023 | Prot_SAP_000.pdf |
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| 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA |
| Participants |
|
| 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 | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | High Risk HPV Positive Cohort | Testing of women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA self-collected via menstrual pad. |
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| Primary | Agreement Between Self-collected Vaginal Swabs vs Clinician-collected Cervical Specimens With High-risk HPV-Positive Results | Participants with with high-risk HPV-positive results and who had cervical specimens collected | Posted | Number | 95% Confidence Interval | percentage of agreement | 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA |
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| Secondary | Number of Participants Who Preferred the Modified Menstrual Pad to Clinician-collected Cervical Specimens | Participants who returned modified menstrual pads and indicated preference on exit survey | Posted | Count of Participants | Participants | 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA |
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| Secondary | Number of Participants Who Opted Out of Self-swab Due to Discomfort With the Procedure | Participants with available data | Posted | Count of Participants | Participants | 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA |
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| 159 |
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| 159 |
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