Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

Stanford University

Status: Completed

Conditions: HPV - Anogenital Human Papilloma Virus Infection

Treatments: Diagnostic Test: Menstrual Blood Analysis (Menstrual Blood Analysis)

Study type: Observational

Funder types: Other

Identifiers

NCT03638427

IRB-47250

GYNCVX0005 (Other Identifier)

NCI-2020-04139 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

159 participants in 1 patient group

High Risk HPV Positive Cohort

Description:

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.

Treatment:

Diagnostic Test: Menstrual Blood Analysis (Menstrual Blood Analysis)