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Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

NCT03638427 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 159

Last updated 2024-05-28

Study results available
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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.

Conditions

  • HPV - Anogenital Human Papilloma Virus Infection

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

Principal Investigators

  • Paul D Blumenthal, MD, MPH · Stanford University, Department of OB/GYN

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-10-11
Completion
2022-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03638427 on ClinicalTrials.gov