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Completed

NCT Number: NCT02785289

A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

The purpose of this study is to compare the performance of cotton and flocked swabs for vaginal self-sampling.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • attending the colposcopy clinic
  • accepts voluntarily to take part to the study and signs the informed consent form

Exclusion criteria

  • pregnancy
  • previous hysterectomy
  • ongoing menstruations

Treatment and study plan

Vaginal swab

Device

Vaginal cell collection will be performed with the two types of indicated swab.

Primary outcomes

  1. Flow cytometric analysis

    Time frame: 1 week

    Number of epithelial cells

  2. Real-time PCR analysis

    Time frame: 1 month

    HPV positivity

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 27, 2016
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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