A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection

NCT ID: NCT02785289

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-09-30

Brief Summary

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

Detailed 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).

Conditions

Human Papillomavirus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Flocked

Patients will perform vaginal cell collection beginning with the flocked swab, followed by the coton swab.

Group Type: EXPERIMENTAL

Vaginal swab

Intervention Type: DEVICE

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

Coton

Patients will perform vaginal cell collection beginning with the coton swab, followed by the flocked swab.

Group Type: EXPERIMENTAL

Vaginal swab

Intervention Type: DEVICE

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

Interventions

Vaginal swab

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Manuela Viviano

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Geneva University Hospitals

Geneva, Switzerland, Switzerland

Countries

Switzerland

Other Identifiers

2016-00412

Identifier Type: -

Identifier Source: org_study_id