Human Papillomavirus InfectionNCT02785289
A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
A study testing Vaginal swab in people with Human Papillomavirus Infection, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare the performance of cotton and flocked swabs for vaginal self-sampling. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Vaginal swab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- attending the colposcopy clinic
- accepts voluntarily to take part to the study and signs the informed consent form
Who cannot join
- pregnancy
- previous hysterectomy
- ongoing menstruations
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the performance of cotton and flocked swabs for vaginal self-sampling.
Read the 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
- Being tested
- Vaginal swab
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal swabDevice
Vaginal cell collection will be performed with the two types of indicated swab.
| Study group | Role | What they receive |
|---|---|---|
| Flocked | Experimental | Patients will perform vaginal cell collection beginning with the flocked swab, followed by the coton swab. Receives: Device: Vaginal swab |
| Coton | Experimental | Patients will perform vaginal cell collection beginning with the coton swab, followed by the flocked swab. Receives: Device: Vaginal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow cytometric analysis
Number of epithelial cells
Measured: 1 week
Real-time PCR analysis
HPV positivity
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuela Viviano, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785289
- Sponsor's protocol ID
- 2016-00412
- Other IDs
- 2016
- Status last verified
- Sep 2016
- First submitted
- 17 May 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
- ClinicalTrials.gov ID
- NCT02785289
- Acronym / sponsor ID
- 2016-00412
- Conditions
- Human Papillomavirus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flocked | Experimental | Device: Vaginal swabPatients will perform vaginal cell collection beginning with the flocked swab, followed by the coton swab. |
| Coton | Experimental | Device: Vaginal swabPatients will perform vaginal cell collection beginning with the coton swab, followed by the flocked swab. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- attending the colposcopy clinic
- accepts voluntarily to take part to the study and signs the informed consent form
Key exclusion criteria (3 listed)
- pregnancy
- previous hysterectomy
- ongoing menstruations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal swabVaginal cell collection will be performed with the two types of indicated swab. | Device | Coton, Flocked |
Primary outcome
Flow cytometric analysis
Time frame: 1 week
Number of epithelial cells
Real-time PCR analysis
Time frame: 1 month
HPV positivity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal swab in people with Human Papillomavirus Infection, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow cytometric analysis (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.