CompletedNot Applicable

Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

United States159 participantsStarted 2019-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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. Exclusion Criteria: * Women younger than 18 years old or are not menstruating regularly

What they're measuring

Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen

Timeframe: 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

Timeframe: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA

Trial details

NCT IDNCT03638427

SponsorStanford University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-10-11

Results submitted2023-10-11

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