Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

HPV - Anogenital Human Papilloma Virus Infection Clinical Trial

Official title:

Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638427
• Other study ID #: IRB-47250
• Secondary ID: NCI-2020-04139GY
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: November 30, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HPV - Anogenital Human Papilloma Virus Infection
• Papilloma
• Papillomavirus Infections
• Uterine Cervical Dysplasia

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Gynecology Clinic	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Naseri S, Young S, Cruz G, Blumenthal PD. Screening for High-Risk Human Papillomavirus Using Passive, Self-Collected Menstrual Blood. Obstet Gynecol. 2022 Sep 1;140(3):470-476. doi: 10.1097/AOG.0000000000004904. Epub 2022 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2-4-months after initial clinician collected samples were obtained and sent for HR-HPV DNA or HPV E6/E7 mRNA
Primary	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	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
Secondary	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