A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
Primary Purpose
Human Papillomavirus Infection
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Vaginal swab
Sponsored by
About this trial
This is an interventional screening trial for Human Papillomavirus Infection
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
Sites / Locations
- Geneva University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Flocked
Coton
Arm Description
Patients will perform vaginal cell collection beginning with the flocked swab, followed by the coton swab.
Patients will perform vaginal cell collection beginning with the coton swab, followed by the flocked swab.
Outcomes
Primary Outcome Measures
Flow cytometric analysis
Number of epithelial cells
Real-time PCR analysis
HPV positivity
Secondary Outcome Measures
Full Information
NCT ID
NCT02785289
First Posted
May 17, 2016
Last Updated
September 12, 2016
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT02785289
Brief Title
A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
Official Title
A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus Infection
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flocked
Arm Type
Experimental
Arm Description
Patients will perform vaginal cell collection beginning with the flocked swab, followed by the coton swab.
Arm Title
Coton
Arm Type
Experimental
Arm Description
Patients will perform vaginal cell collection beginning with the coton swab, followed by the flocked swab.
Intervention Type
Device
Intervention Name(s)
Vaginal swab
Intervention Description
Vaginal cell collection will be performed with the two types of indicated swab.
Primary Outcome Measure Information:
Title
Flow cytometric analysis
Description
Number of epithelial cells
Time Frame
1 week
Title
Real-time PCR analysis
Description
HPV positivity
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
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