Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

Completed

• Conditions: HPV - Anogenital Human Papilloma Virus Infection
• Interventions: Diagnostic Test: Menstrual Blood Analysis (Menstrual Blood Analysis)

• Registration Number: NCT03638427
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Study Start: 2019-01-01
• Primary Completion: 2022-10-11
• Study Completion: 2022-11-30
• Results First Submitted: 2023-10-11
• Status Verified: 2024-04
• Results First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Results First Posted: 2024-05-28
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 159

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.

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Exclusion Criteria

• Women younger than 18 years old or are not menstruating regularly

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High Risk HPV Positive Cohort	Menstrual Blood Analysis (Menstrual Blood Analysis)	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.

Primary Outcome Measures

Name	Time	Method
Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen	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.
Agreement Between Self-collected Vaginal Swabs vs Clinician-collected Cervical Specimens With High-risk HPV-Positive Results	2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford Gynecology Clinic; 🇺🇸 Palo Alto, California, United States