Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

Stanford University159 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

159

Conditions

HPV - Anogenital Human Papilloma Virus Infection

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Stanford Gynecology Clinic

Palo Alto, California, United States

Outcomes

Primary Outcomes

Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen

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.

Time frame: 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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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