Trial Outcomes & Findings for Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood (NCT NCT03638427)

NCT ID: NCT03638427

Last Updated: 2024-05-28

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 159 participants
• Primary outcome timeframe: 2-4-months after initial clinician collected samples were obtained and sent for HR-HPV DNA or HPV E6/E7 mRNA
• Results posted on: 2024-05-28

Participant Flow

Participant milestones

Measure	High Risk HPV Positive Cohort Testing of women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA self-collected via menstrual pad.
Overall Study STARTED	159
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	49

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood

Baseline characteristics by cohort

Measure	High Risk HPV Positive Cohort n=159 Participants Testing of women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA self-collected via menstrual pad.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	159 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	133 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	55 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants
Region of Enrollment United States	159 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-4-months after initial clinician collected samples were obtained and sent for HR-HPV DNA or HPV E6/E7 mRNA

Population: Participants with specimens meeting clinical criteria for each analysis category

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.

Outcome measures

Measure	High Risk HPV Positive Cohort n=46 Participants Testing of women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA self-collected via menstrual pad.
Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen Participants who returned sample within 2 months	93.5 percentage of agreement Interval 82.5 to 97.8
Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen Participants with dysplasia CIN2 or worse	100 percentage of agreement Interval 32.5 to 100.0
Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen Participants with dysplasia CIN2 worse and participants with lab results showing high-risk HPV	100 percentage of agreement Interval 40.2 to 100.0

PRIMARY outcome

Timeframe: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA

Population: Participants with with high-risk HPV-positive results and who had cervical specimens collected

Outcome measures

Measure	High Risk HPV Positive Cohort n=37 Participants Testing of women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA self-collected via menstrual pad.
Agreement Between Self-collected Vaginal Swabs vs Clinician-collected Cervical Specimens With High-risk HPV-Positive Results	88.1 percentage of agreement Interval 75.0 to 94.8

SECONDARY outcome

Timeframe: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA

Population: Participants who returned modified menstrual pads and indicated preference on exit survey

Outcome measures

Measure	High Risk HPV Positive Cohort n=83 Participants Testing of women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA self-collected via menstrual pad.
Number of Participants Who Preferred the Modified Menstrual Pad to Clinician-collected Cervical Specimens	78 Participants

SECONDARY outcome

Timeframe: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA

Population: Participants with available data

Outcome measures

Measure	High Risk HPV Positive Cohort n=141 Participants Testing of women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA self-collected via menstrual pad.
Number of Participants Who Opted Out of Self-swab Due to Discomfort With the Procedure	32 Participants

Adverse Events

High Risk HPV Positive Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Blumenthal, MD

Stanford University

Phone: (650) 725-6035

Email: gynresearch@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place