Trial Outcomes & Findings for HPV Typing Between Self- and Physician-sampled (NCT NCT04472377)

Results Overview

Rate of the "agreement". The "agreement" is defined as either (1) presence of any high-risk HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of high-risk HPV in physician collected specimen and the patient sampled specimen.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1210 participants

Primary outcome timeframe

14 days

Results posted on

2024-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Study Population We enroll a total of 1,200 women, as follows, 1. 120 cases with no history or current cervical intraepithelial lesion or malignancy. 2. 180 cases with a history of abnormal Pap test including ASCUS, CIN1, or atypical glandular cell. 3. 240 cases with a history of atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma. 4. 240 cases with current ASCUS, CIN1, or atypical glandular cell. 5. 420 cases with current abnormal Pap test as atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma. Self sampling kit for collecting discharge from vaginal fornix: A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.
Overall Study STARTED	1210
Overall Study COMPLETED	1210
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Population n=1210 Participants We enroll a total of 1,200 women, as follows, 1. 120 cases with no history or current cervical intraepithelial lesion or malignancy. 2. 180 cases with a history of abnormal Pap test including ASCUS, CIN1, or atypical glandular cell. 3. 240 cases with a history of atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma. 4. 240 cases with current ASCUS, CIN1, or atypical glandular cell. 5. 420 cases with current abnormal Pap test as atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma. Self sampling kit for collecting discharge from vaginal fornix: A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.
Age, Continuous	45.3 years STANDARD_DEVIATION 10.2 • n=1210 Participants
Sex: Female, Male Female	1210 Participants n=1210 Participants
Sex: Female, Male Male	0 Participants n=1210 Participants

PRIMARY outcome

Timeframe: 14 days

Rate of the "agreement". The "agreement" is defined as either (1) presence of any high-risk HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of high-risk HPV in physician collected specimen and the patient sampled specimen.

Outcome measures

Outcome measures
Measure	Self-collected Specimens n=1170 Participants The high-risk HPV test results of the samples collected by the participants	Physician-sampled Specimens n=1170 Participants The high-risk HPV test results of the samples collected by the physician
Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. Positive	581 Participants	611 Participants
Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. Negative	589 Participants	559 Participants

SECONDARY outcome

Timeframe: 14 days

Rate of the "agreement". The "agreement" is defined as either (1) presence of any HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of any HPV in physician collected specimen and the patient sampled specimen.

Outcome measures

Outcome measures
Measure	Self-collected Specimens n=1170 Participants The high-risk HPV test results of the samples collected by the participants	Physician-sampled Specimens n=1170 Participants The high-risk HPV test results of the samples collected by the physician
Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample Positive	718 Participants	720 Participants
Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample Negative	452 Participants	450 Participants

SECONDARY outcome

Timeframe: 14 days

Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens.

Outcome measures

Outcome measures
Measure	Self-collected Specimens n=1170 Participants The high-risk HPV test results of the samples collected by the participants	Physician-sampled Specimens n=1170 Participants The high-risk HPV test results of the samples collected by the physician
Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens	1170 Participants	1170 Participants

SECONDARY outcome

Timeframe: within one month after sample collection

The number of participants with any adverse event.

Outcome measures

Outcome measures
Measure	Self-collected Specimens n=1210 Participants The high-risk HPV test results of the samples collected by the participants	Physician-sampled Specimens The high-risk HPV test results of the samples collected by the physician
Adverse Event From Self Sampling	9 Participants	—

Adverse Events

Participants With Adverse Events

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants With Adverse Events n=1210 participants at risk study device-related adverse events
Product Issues Perineal pain	0.58% 7/1210 • 1 months
Product Issues anxiety	0.17% 2/1210 • 1 months

Additional Information

Lance Yang

Hygeia Touch Inc.

Phone: +886-3-6675616

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place