NCT04472377 · REGISTRY CONDITION SEARCH

HPV Typing Between Self- and Physician-sampled

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2024-10-03

Hygeia Touch Inc. developed a safe and comfortable vaginal self-sampling device "Hygeia Touch Self Sampling Kit for Women" to self-collect the vaginal discharge sample for high-risk Human Papillomavirus (hrHPV) detection. This clinical trial aimed to evaluate the agreement of hrHPV detections between vaginal self-sampling using "Hygeia Touch Self Sampling Kit for Women" and physician sampling, and these results will be applied for TFDA registration approval.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen.

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outcome · POSTED

Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample

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outcome · POSTED

Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens

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outcome · POSTED

Adverse Event From Self Sampling

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1\. Woman with a uterine cervix, i.e., with no previous total hysterectomy or radiotherapy for cervical tumor. The woman who received subtotal hysterectomy is allowed. 2\. Signed informed consent. 3. Fit any one of the following conditions, 1. with no history or current cervical intraepithelial lesion or malignancy. 2. with a history of abnormal Pap test including atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell. 3. with a history of atypical squamous cells favor high-grade squamous intraepithelial lesion, dysplasia cannot exclude high-grade squamous intraepithelial lesion, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma. 4. with current atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell. 5. with current abnormal Pap test as atypical squamous cells favor high-grade squamous intraepithelial lesion, dysplasia cannot exclude high-grade squamous intraepithelial lesion, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma. Exclusion Criteria: 1. History of total hysterectomy 2. Pregnant 3. Current cervicitis that requires therapy 4. Received treatment for cervical lesion within 90 days 5. Had undergone radiotherapy or is receiving radiation over the uterus, cervix or vagina 6. Had sexual activity without a condom in 48 hours 7. Excessive vaginal discharge, either in the ovulation period or due to inflammation 8. is undergoing local therapy with an intravaginal tablet or residual drug in the vaginal canal 9. during mense
gender Based: true
gender Description: Detection of HPV in female genital tract.
healthy Volunteers: true
maximum Age: 65 Years
minimum Age: 21 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Device: Self sampling kit for collecting discharge from vaginal fornix
label
study population
type
EXPERIMENTAL

interventions

arm Group Labels
study population
description
A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.
name
Self sampling kit for collecting discharge from vaginal fornix
other Names
Hygeia Touch Self Sampling Kit for Women
type
DEVICE

Study design

allocation

intervention Model

SINGLE_GROUP

intervention Model Description

Two samples were collected, one by the study investigator using a cervical swab and another one by the patient using the study device immediately after viewing the instruction video and illustration. The association of the self-collected sample and the physician-collected sample was blinded to the laboratory personnel.

masking Info

masking: NONE
masking Description: the specimen was marked by code which was intended to mask the sample pairing

primary Purpose

DIAGNOSTIC

Enrollment

count: 1210
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen.
time Frame
14 days

secondary Outcomes

description
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.
measure
Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample
time Frame
14 days
description
Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens.
measure
Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens
time Frame
14 days
description
The number of participants with any adverse event.
measure
Adverse Event From Self Sampling
time Frame
within one month after sample collection

Full study description

brief Summary: Hygeia Touch Inc. developed a safe and comfortable vaginal self-sampling device "Hygeia Touch Self Sampling Kit for Women" to self-collect the vaginal discharge sample for high-risk Human Papillomavirus (hrHPV) detection. This clinical trial aimed to evaluate the agreement of hrHPV detections between vaginal self-sampling using "Hygeia Touch Self Sampling Kit for Women" and physician sampling, and these results will be applied for TFDA registration approval.
detailed Description: Primary end-point: 1. Agreement of hr-HPV types, including types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, between the physician-collected sample and self-collected sample 2. Agreement of the presence of hr-HPV between the physician-collected sample and self-collected sample Secondary end-point: 1. Percentage of the valid sample between self-collected and physician-collected specimens 2. Agreement of all (N = 27) HPV types between the paired samples 3. Adverse events associated with sample collection 4. Questionnaire of the appreciation and satisfaction of using self-collecting vaginal discharge sample using "Hygeia Touch Self Sampling Kit for Women" through a short movie and a brief illustration 5. Correlation between histological diagnosis and HPV types

Source references

references

citation
Chou HH, Yang CY, Chao A, Lin H, Lu CH, Ou YC, Hsu ST, Shih YH, Huang HJ, Lin CT, Chen MY, Sun L, Tsai CC, Fu HC, Huang KG, Wu KY, Wu CH, Hsieh WC, Huang YT, Chen LH, Yang LY, Chang WY, Chang TC, Lai CH. Consistency in human papillomavirus type detection between self-collected vaginal specimens and physician-sampled cervical specimens. J Med Virol. 2024 Mar;96(3):e29426. doi: 10.1002/jmv.29426.
pmid
38420851
type
RESULT
citation
Yang CY, Chang TC, Chou HH, Chao A, Hsu ST, Shih YH, Huang HJ, Lin CT, Chen MY, Sun L, Huang KG, Wu KY, Hsieh WC, Huang YT, Chen LH, Lu CH, Lin H, Cheng CM. Evaluation of a novel vaginal cells self-sampling device for human papillomavirus testing in cervical cancer screening: A clinical trial assessing reliability and acceptability. Bioeng Transl Med. 2024 Mar 13;9(4):e10653. doi: 10.1002/btm2.10653. eCollection 2024 Jul.
pmid
39036090
type
RESULT
citation
Yang CY, Chang TC, Lee YT, Shih TY, Li CW, Cheng CM. Exploring the Interplay Between Cervicovaginal Microbiome, HPV Infection, and Cervical Intraepithelial Neoplasia in Taiwanese Women. J Med Virol. 2025 Feb;97(2):e70190. doi: 10.1002/jmv.70190.
pmid
39868896
type
DERIVED

Source notices and limitations

Discovery and provenance

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exact text
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query cond
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query disease state id
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Preserved source evidence · Not medical advice