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Completed

NCT Number: NCT04472377

HPV Typing Between Self- and Physician-sampled

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.

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Key information

Conditions

Human Papillomavirus Infection Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Self Sampling Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Vaginal Discharge Vaginal Diseases Virus Diseases

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

Treatment and study plan

Self sampling kit for collecting discharge from vaginal fornix

Device

A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.

Other names: Hygeia Touch Self Sampling Kit for Women

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 14 days

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

  3. Adverse Event From Self Sampling

    Time frame: within one month after sample collection

    The number of participants with any adverse event.

Sponsors and collaborators

Lead sponsor

Hygeia Touch Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 15, 2020
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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