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OpenTrials
Completed

NCT Number: NCT03638427

Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

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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Key information

Conditions

HPV - Anogenital Human Papilloma Virus Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Stanford Gynecology Clinic

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menstrual Blood Analysis (Menstrual Blood Analysis)

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.

Primary outcomes

  1. 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. 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

Secondary outcomes

  1. 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. 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2018
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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