A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

Human Papillomavirus Infection Clinical Trial

Official title:

A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785289
• Other study ID #: 2016-00412
• Status: Completed
• Phase: N/A
• First received: May 17, 2016
• Last updated: September 12, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow cytometric analysis	Number of epithelial cells	1 week	No
Primary	Real-time PCR analysis	HPV positivity	1 month	No