Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- specificity
研究概览
简要总结
Papillomaviruses are responsible for almost all cervical cancers. In France, there are more than 3000 new cases of cervical cancer each year and nearly 1000 deaths. One of the ways to prevent this cancer is screening by PCR on cervical sample for which national coverage rate remains very insufficient (<60%). The invasive and uncomfortable nature of cervical sampling has been identified as a major obstacle to screening. In this context, an alternative sample, such as the first-void urine, seems to be judicious. Nevertheless, some studies have shown a lack of sensitivity of the HPV PCR test on urine. As underlined by the French National Authority for Health (HAS), this is mainly due to a lack of standardization of urine collection. In this study, the investigators therefore propose to evaluate the performance of the HPV PCR test on first-void urine using a standardized protocol. Through a questionnaire, they will also evaluate the acceptability of the first void urine collection device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 30 and 65
- •Consulting in the Gynecology-Obstetrics department for primary cervical cancer screening
- •Patient affiliated or entitled to a social security regimen
- •Patient who has received information about the study and expressed non-opposition
排除标准
- 未提供
研究组 & 干预措施
Primary screening for UCC
Women aged between 30 and 65 who are candidates for primary screening for UCC will be included.
干预措施: Urine sample, 1st stream (Other)
Primary screening for UCC
Women aged between 30 and 65 who are candidates for primary screening for UCC will be included.
干预措施: Cervico-vaginal swab (Other)
结局指标
主要结局
specificity
时间窗: Month : 12
specificity (%) of the HPV PCR test on the first void urine (Colli-Pee®) in comparison with the same HPV PCR test applied to the cervical sampling (= gold standard).
Sensitivity
时间窗: Month : 12
Sensitivity (%) of the HPV PCR test on the first void urine (Colli-Pee®) in comparison with the same HPV PCR test applied to the cervical sampling (= gold standard).
次要结局
- Women with a positive evaluation(Month : 12)
- HPV genotype concordance(Month : 12)