The Agreement of hrHPV Detections Between Vaginal Self-sampling and Physician Sampling

Overview

Hygeia Touch Inc. has developed a safe and comfortable vaginal self-sampling device "Hygeia Touch Self Sampling Kit for Women" to self-collect the vaginal samples 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.

Full Title of Study: “Evaluate the Agreement of High-risk Human Papillomavirus (hrHPV) Detections Between Vaginal Self-sampling Using “Hygeia Touch Self Sampling Kit for Women” and Physician Sampling”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2022

Interventions

  • Device: 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.

Arms, Groups and Cohorts

  • Experimental: study population
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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 Eligibility: Female

Detection of HPV in female genital tract.

Minimum Age: 21 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hygeia Touch Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hung-Hsueh Chou, MBBS, VS, Study Chair, Chang Gung Memorial Hospital
  • Overall Contact(s)
    • Hung-Hsueh Chou, MBBS, VS, +886 3 3281200, ma2012@cgmh.org.tw

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