N/A
N=159
Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood
HPV - Anogenital Human Papilloma Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT03638427 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen — 93.5; 100; 100 percentage of agreement
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Menstrual Blood Analysis (Menstrual Blood Analysis) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen |
93.5; 100; 100 | — |
| PRIMARY Agreement Between Self-collected Vaginal Swabs vs Clinician-collected Cervical Specimens With High-risk HPV-Positive Results |
88.1 | — |
| SECONDARY Number of Participants Who Preferred the Modified Menstrual Pad to Clinician-collected Cervical Specimens |
78 | — |
| SECONDARY Number of Participants Who Opted Out of Self-swab Due to Discomfort With the Procedure |
32 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03638427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.