HPV - Anogenital Human Papilloma Virus Infection
Conditions
Keywords
menstrual blood, high risk HPV
Brief summary
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.
Interventions
DIAGNOSTIC_TESTMenstrual 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.
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
* Women younger than 18 years old or are not menstruating regularly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen | 2-4-months after initial clinician collected samples were obtained and sent for HR-HPV DNA or HPV E6/E7 mRNA | 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. |
| 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 | — |
Secondary
| Measure | 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 | 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 159 |
| Total | 159 |
Baseline characteristics
| Characteristic | High Risk HPV Positive Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 159 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 133 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 55 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 74 Participants |
| Region of Enrollment United States | 159 Participants |
| Sex: Female, Male Female | 159 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 159 |
| other Total, other adverse events | 0 / 159 |
| serious Total, serious adverse events | 0 / 159 |
Outcome results
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 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
Population: Participants with specimens meeting clinical criteria for each analysis category
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Risk HPV Positive Cohort | Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen | Participants who returned sample within 2 months | 93.5 percentage of agreement |
| High Risk HPV Positive Cohort | Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen | Participants with dysplasia CIN2 or worse | 100 percentage of agreement |
| High Risk HPV Positive Cohort | Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen | Participants with dysplasia CIN2 worse and participants with lab results showing high-risk HPV | 100 percentage of agreement |
Primary
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
Population: Participants with with high-risk HPV-positive results and who had cervical specimens collected
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Risk HPV Positive Cohort | Agreement Between Self-collected Vaginal Swabs vs Clinician-collected Cervical Specimens With High-risk HPV-Positive Results | 88.1 percentage of agreement |
Secondary
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
Population: Participants with available data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Risk HPV Positive Cohort | Number of Participants Who Opted Out of Self-swab Due to Discomfort With the Procedure | 32 Participants |
Secondary
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
Population: Participants who returned modified menstrual pads and indicated preference on exit survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Risk HPV Positive Cohort | Number of Participants Who Preferred the Modified Menstrual Pad to Clinician-collected Cervical Specimens | 78 Participants |