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临床试验/NCT02785289
NCT02785289已完成不适用

A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manuela Viviano

Dr.

University Hospital, Geneva

研究点 (2)

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