NCT04472377已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,210
- 试验地点
- 6
- 主要终点
- Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
the specimen was marked by code which was intended to mask the sample pairing
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •History of total hysterectomy
- •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
结局指标
主要结局
Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen.
时间窗: 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.
次要结局
- Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample(14 days)
- Adverse Event From Self Sampling(within one month after sample collection)
- Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens(14 days)
研究者
研究点 (6)
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