Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

May 23, 2024 updated by: Paul D Blumenthal, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Gynecology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Menstruating women over the age of 18.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen
Time Frame: 2-4-months after initial clinician collected samples were obtained and sent for HR-HPV DNA or HPV E6/E7 mRNA

The clinician collected a vaginal swab to detect HPV, then participants used a modified menstrual pad to self-collect a sample within 2 months of the clinician collected swab (may have happened at up to 4 mo.). Participants may have had prior history of dysplasia or HPV positivity, or were from general population receiving regular check-up.

Agreement between the clinician-collected swabs and participant-collected menstrual samples was assessed in:

  • Participants who sent their sample to the lab within 2 months, and whose sample was analyzed for the presence of HPV
  • Participants enrolled at the time of a previously scheduled colposcopy, with a biopsy taken (if clinically appropriate) showing moderate-to-severe dysplasia (cervical intraepithelial neoplasia [CIN] 2 or worse)
  • Participants enrolled at the time of a previously scheduled colposcopy, with a biopsy taken showing moderate-to-severe dysplasia, and participants whose laboratory results indicated presence of high-risk HPV.
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
Time Frame: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA
2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Preferred the Modified Menstrual Pad to Clinician-collected Cervical Specimens
Time Frame: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA
2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA
Number of Participants Who Opted Out of Self-swab Due to Discomfort With the Procedure
Time Frame: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA
2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Paul D Blumenthal, MD, MPH, Stanford University, Department of OB/GYN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

October 11, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-47250
  • NCI-2020-04139 (Registry Identifier: CTRP)
  • GYNCVX0005 (Other Identifier: Stanford OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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