An observational study in HPV - Anogenital Human Papilloma Virus Infection, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Stanford University · Observational
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.
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's enrollment of 159 is below the median of 400 across 147 observational studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Menstruating women over the age of 18.
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:
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.
Diagnostic Test: Menstrual Blood Analysis (Menstrual Blood Analysis)
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.
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 who sent their sample to the lab within 2 months, and whose sample was analyzed for the presence of HPV * Participants enrolled at the time of a previously scheduled colposcopy, with a biopsy taken (if clinically appropriate) showing moderate-to-severe dysplasia (cervical intraepithelial neoplasia \[CIN\] 2 or worse) * Participants enrolled at the time of a previously scheduled colposcopy, with a biopsy taken showing moderate-to-severe dysplasia, and participants whose laboratory results indicated presence of high-risk HPV.
Time frame: 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
Time frame: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA
Number of Participants Who Preferred the Modified Menstrual Pad to Clinician-collected Cervical Specimens
Time frame: 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
Time frame: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA
| Milestone | High Risk HPV Positive Cohort |
|---|---|
| Started | 159 |
| Completed | 110 |
| Not completed | 49 |
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 who sent their sample to the lab within 2 months, and whose sample was analyzed for the presence of HPV * Participants enrolled at the time of a previously scheduled colposcopy, with a biopsy taken (if clinically appropriate) showing moderate-to-severe dysplasia (cervical intraepithelial neoplasia \[CIN\] 2 or worse) * Participants enrolled at the time of a previously scheduled colposcopy, with a biopsy taken showing moderate-to-severe dysplasia, and participants whose laboratory results indicated presence of high-risk HPV.
| percentage of agreement | High Risk HPV Positive Cohort |
|---|---|
| Participants who returned sample within 2 months | 93.5 (82.5 to 97.8) |
| Participants with dysplasia CIN2 or worse | 100 (32.5 to 100) |
| Participants with dysplasia CIN2 worse and participants with lab results showing high-risk HPV | 100 (40.2 to 100) |
| percentage of agreement | High Risk HPV Positive Cohort |
|---|---|
| Agreement Between Self-collected Vaginal Swabs vs Clinician-collected Cervical Specimens With High-risk HPV-Positive Results | 88.1 (75.0 to 94.8) |
| Participants | High Risk HPV Positive Cohort |
|---|---|
| Number of Participants Who Preferred the Modified Menstrual Pad to Clinician-collected Cervical Specimens | 78 |
| Participants | High Risk HPV Positive Cohort |
|---|---|
| Number of Participants Who Opted Out of Self-swab Due to Discomfort With the Procedure | 32 |
Collected over On average up to 120 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Risk HPV Positive Cohort | 0/159 (0%) | 0/159 (0%) | 0/159 (0%) |
| Age, Categorical(Participants) | High Risk HPV Positive Cohort |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 159 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | High Risk HPV Positive Cohort |
|---|---|
| Female | 159 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | High Risk HPV Positive Cohort |
|---|---|
| Hispanic or Latino | 22 |
| Not Hispanic or Latino | 133 |
| Unknown or Not Reported | 4 |
| Race (NIH/OMB)(Participants) | High Risk HPV Positive Cohort |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 55 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 4 |
| White | 74 |
| More than one race | 3 |
| Unknown or Not Reported | 21 |
| Region of Enrollment(Participants) | High Risk HPV Positive Cohort |
|---|---|
| United States | 159 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stanford University