Agreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface

Study Overview
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Brief Summary
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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
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Primary end-point: 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 Agreement of the presence of hr-HPV between the physician-collected sample and self-collected sample Secondary end-point: Percentage of the valid sample between self-collected and physician-collected specimens Agreement of all (N = 27) HPV types between the paired samples Adverse events associated with sample collection 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 Correlation between histological diagnosis and HPV types

Official Title
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Evaluate the Agreement of High-risk Human Papillomavirus Type Between Self-collected Vaginal Discharge Sample Using HygeiaTouch Self Sampling Kit for Woman and Physician Collected Sample From the Cervix

Conditions
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Human Papillomavirus Infection, Self Sampling, Vaginal Discharge

Intervention / Treatment
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* Device: Self sampling kit for collecting discharge from vaginal fornix


Participation Criteria
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Eligibility Criteria
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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, with no history or current cervical intraepithelial lesion or malignancy. with a history of abnormal Pap test including atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell. 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. with current atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell. 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: History of total hysterectomy Pregnant Current cervicitis that requires therapy Received treatment for cervical lesion within 90 days Had undergone radiotherapy or is receiving radiation over the uterus, cervix or vagina Had sexual activity without a condom in 48 hours Excessive vaginal discharge, either in the ovulation period or due to inflammation is undergoing local therapy with an intravaginal tablet or residual drug in the vaginal canal during mense

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study population<br>We enroll a total of 1,200 women, as follows, 120 cases with no history or current cervical intraepithelial lesion or malignancy. 180 cases with a history of abnormal Pap test including ASCUS, CIN1, or atypical glandular cell. 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. 240 cases with current ASCUS, CIN1, or atypical glandular cell. 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. | Device: Self sampling kit for collecting discharge from vaginal fornix<br>* A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.<br>* Other names: Hygeia Touch Self Sampling Kit for Women;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement in the detection of high-risk HPV type in physician collected specimen and patient sampled specimen. | 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. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement in HPV detection between physician collected sample and self-collected sample | 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. | through study completion, an average of 1 year | 
| Percentage of a valid specimen, according to the presence of the beta-globin gene in the self-collected specimen, and compares to the physician-collected specimen | Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens. | through study completion, an average of 1 year | 
| Any adverse event resulted from collecting the specimen | The number of participants with any adverse event. | within one month after sample collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical screening, human papillomavirus typing, self sampling