NCT05600283已完成不适用
Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection
研究概览
简要总结
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Researchers will compare the laboratory results of self-collected vaginal swab samples to usual healthcare provider-collected cervical swab samples to determine the laboratory HPV testing accuracy of the self-collection swab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Appointment at Mayo Clinic Rochester in Gynecology Colposcopy Clinic or ICS (integrated community specialty) Colposcopy Clinic (will always include a speculum exam).
- •Appointment at Mayo Clinic Rochester in Gynecology Clinic for indication that will already include a speculum exam (e.g., cervical cancer screening or IUD insertion).
排除标准
- •Excluded if self-reported as currently menstruating, pregnant, or within 3 months following pregnancy.
- •Excluded if no cervix (history of total hysterectomy).
- •Excluded if moderate to heavy vaginal bleeding on the day of the visit.
- •Excluded if reason for visit in Gynecology Clinic is abnormal vaginal discharge.
- •Exclude patients who are on Gynecology Colposcopy Clinic for LEEP (loop electrosurgical excision procedure).
- •Exclude if any use of over-the-counter or prescription vaginal cream for vaginal infection or prescription vaginal estrogen cream for at least two days before using the Evalyn Brush.
- •(Vaginal contraceptives, condoms and water-based lubricants can be used as normal.)
结局指标
主要结局
Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection
时间窗: Baseline (sample was collected up to 21 days form the date of registration)
Patient-collected vaginal swab HPV results compared with gold standard of clinician-collected cervical swab) to accurately detect HPV infection
次要结局
- Patient-reported Acceptability of Using the Evalyn Brush(Baseline (sample was collected up to 21 days form the date of registration))
研究者
研究点 (1)
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