Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-11-30

Brief Summary

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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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Detailed Description

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Conditions

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HPV - Anogenital Human Papilloma Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Menstrual Blood Analysis (Menstrual Blood Analysis)

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.