A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Flow cytometric analysis
研究概览
简要总结
The purpose of this study is to compare the performance of cotton and flocked swabs for vaginal self-sampling.
详细描述
Vaginal self-sampling for Human Papillomavirus (HPV) testing has been proposed as an efficient method cover hard-to reach populations in developing countries. While the recent cheap cotton swabs have traditionally been used for deoxyribonucleic acid (DNA) detection, recent studies have questioned their efficacy by reporting the superiority of the more expensive flocked swabs.
The objective of this study is to compare the performance of cotton vs flocked swabs for cellular retrieval and HPV DNA quantification after vaginal self-sampling.
A total of 120 women will be recruited. Inclusion criteria will be as follows: 21 years of age or older, attending the colposcopy clinic, understanding the study procedures and able to comply with the study protocol. Pregnant women, those having previously had a total hysterectomy, and women with ongoing menstruation will be excluded. Each woman will collect two different vaginal self samples: one with the cotton swab and one with the flocked swab. Subsequently, a flow cytometric analysis, as well as a real time PCR analysis and a cytologic evaluation for specimen adequacy will be run on each sample. Agreement between the two methods will be calculated using the kappa statistic (κ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •attending the colposcopy clinic
- •accepts voluntarily to take part to the study and signs the informed consent form
排除标准
- •pregnancy
- •previous hysterectomy
- •ongoing menstruations
结局指标
主要结局
Flow cytometric analysis
时间窗: 1 week
Number of epithelial cells
Real-time PCR analysis
时间窗: 1 month
HPV positivity
次要结局
未报告次要终点
研究者
Manuela Viviano
Dr.
University Hospital, Geneva
