Human Papillomavirus InfectionHPVDryNCT01316120
Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs
A study testing Compare different self-obtained specimen for HPV identification in people with Human Papillomavirus Infection, run by University Hospital, Geneva.
Trial summary
Human papillomavirus (HPV) assays are likely to be used in cervical cancer screening. Our objective is to simplify the method of collection of female genital tract specimens by determining if vaginal dry swabs are as accurate as the standard transport medium for HPV diagnosis. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Compare different self-obtained specimen for HPV identification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Dec 2011
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 years or older,
- First consultation in our colposcopy unit,
- Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF).
Who cannot join
- Previous hysterectomy,
- Pregnant,
- Virgin,
- Not able to comply with the protocol study.
About this study
Human papillomavirus (HPV) assays are likely to be used in cervical cancer screening. Our objective is to simplify the method of collection of female genital tract specimens by determining if vaginal dry swabs are as accurate as the standard transport medium for HPV diagnosis.
Read the detailed description
High-risk human papillomavirus (HR-HPV) infections in women are clinically important because they have been associated with nearly all cases of preinvasive and invasive cervical neoplasia1. Genital HR-HPV related infection is common, affecting approximately 10-25% of women, depending on the population and age-groups studied2-4.
With the advance in our understanding of HPV biology and the development of technologies for HPV detection together with the poor sensitivity of a single Pap test, there has been now a growing interest concerning the potential use of HPV DNA testing as a screening tool for cervical cancer5.
Currently, there is no consensus on which sampling method is the most effective for HPV DNA testing. These last years, studies have reported that samples provided by women themselves were suitable for DNA testing and support the feasibility of self-collection for HPV DNA testing6-8. Data from these studies support that it is acceptable for the women and demonstrated that a fairly high concordance rate between the self- and physicians testing method has been achieved.
Potential advantage of self-collection is that it could improve access to health care, reduce healthcare costs and save time for patients and providers. Available data have been reported with the use of specimen transport medium (STM), but the use of dry vaginal swab may potentially offer similar reliability than standard STM. Small studies suggest that HPV test (PCR) sampled by physicians using dry vaginal swab seems to be as accurate as those performed in a standard medium for HPV detection9,10. Dry vaginal swab offers potential advantages in terms of being more convenient for collection and is less expensive than a vaginal swab placed in a transport medium.
The aim of our study is to assess the performance of self-obtained v-DRY versus "standard" v-STM and its acceptability.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Compare different self-obtained specimen for HPV identification
- Keywords
- Self-collected vaginal samples, HPV, HPV self-obtained sample, HPV specimen transport medium
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compare different self-obtained specimen for HPV identificationOther
Instructions will be given to the patients by a research nurse and ICF will be obtained. For specimen collection, participants will be instructed to wash their hands before the procedure. Each participant will receive a package containing a specimen collection kit. Recommendations will be to hold the swab by the end of the handle, to insert the swab into the vagina avoiding contact with the external genitalia, rotate 1 round and to replace the swab in a plastic sleeve (v-DRY) or in a tube containing specimen transport medium (v-STM),.
Compare different self-obtained specimen for HPV identificationOther
Instructions will be given to the patients by a research nurse and ICF will be obtained. For specimen collection, participants will be instructed to wash their hands before the procedure. Each participant will receive a package containing a specimen collection kit. Recommendations will be to hold the swab by the end of the handle, to insert the swab into the vagina avoiding contact with the external genitalia, rotate 1 round and to replace the swab in a plastic sleeve (v-DRY) or in a tube containing specimen transport medium (v-STM),.
| Study group | Role | What they receive |
|---|---|---|
| HPV Dry first | Experimental | Randomization will determine the sequence of the two tests, avoiding potential bias that may advantage the "first" test. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic tests Receives: Other: Compare different self-obtained specimen for HPV identification |
| HPV standard transport medium | Experimental | Randomization will determine the sequence of the two tests, avoiding potential bias that may advantage the "first" test. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic tests Receives: Other: Compare different self-obtained specimen for HPV identification |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess sensibility and specificity of dry swabs for HPV diagnosis
Agreement between collection methods in terms of HPV risk categories will be measured using the kappa statistic ( ) with a precision of 10% (95% confidence interval). This measure of agreement is 0 when the amount of agreement is what would be expected by chance and 1 when there is perfect agreement.
Measured: day 1
Secondary outcomes (2)
Preference about HPV self-collection
Women will complete a self administered questionnaire on demographics and preference for sampling method (Dry versus standard)
Measured: day 1
Sensitivity and specificity of specimen transport medium (STM)
Sensitivity and specificity to detect high-risk HPV using v-STM as gold standard will be reported.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionAug 2011
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Eperon, University Hospital, Geneva
- Investigators
- Patrick Petignat, Prof, Study director, HUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316120
- Sponsor's protocol ID
- HPVDry
- Acronym
- HPVDry
- Status last verified
- Dec 2011
- First submitted
- 15 Mar 2011
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Eperon I, Vassilakos P, Navarria I, Menoud PA, Gauthier A, Pache JC, Boulvain M, Untiet S, Petignat P. Randomized comparison of vaginal self-sampling by standard vs. dry swabs for human papillomavirus testing. BMC Cancer. 2013 Jul 22;13:353. doi: 10.1186/1471-2407-13-353.
PubMed 23875668
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs
- ClinicalTrials.gov ID
- NCT01316120
- Acronym / sponsor ID
- HPVDry / HPVDry
- Conditions
- Human Papillomavirus Infection
- Keywords
- Self-collected vaginal samples, HPV, HPV self-obtained sample, HPV specimen transport medium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 16 Mar 2011 (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.
Human papillomavirus (HPV) assays are likely to be used in cervical cancer screening. Our objective is to simplify the method of collection of female genital tract specimens by determining if vaginal dry swabs are as accurate as the standard transport medium for HPV diagnosis.
Detailed description
High-risk human papillomavirus (HR-HPV) infections in women are clinically important because they have been associated with nearly all cases of preinvasive and invasive cervical neoplasia1. Genital HR-HPV related infection is common, affecting approximately 10-25% of women, depending on the population and age-groups studied2-4.
With the advance in our understanding of HPV biology and the development of technologies for HPV detection together with the poor sensitivity of a single Pap test, there has been now a growing interest concerning the potential use of HPV DNA testing as a screening tool for cervical cancer5.
Currently, there is no consensus on which sampling method is the most effective for HPV DNA testing. These last years, studies have reported that samples provided by women themselves were suitable for DNA testing and support the feasibility of self-collection for HPV DNA testing6-8. Data from these studies support that it is acceptable for the women and demonstrated that a fairly high concordance rate between the self- and physicians testing method has been achieved.
Potential advantage of self-collection is that it could improve access to health care, reduce healthcare costs and save time for patients and providers. Available data have been reported with the use of specimen transport medium (STM), but the use of dry vaginal swab may potentially offer similar reliability than standard STM. Small studies suggest that HPV test (PCR) sampled by physicians using dry vaginal swab seems to be as accurate as those performed in a standard medium for HPV detection9,10. Dry vaginal swab offers potential advantages in terms of being more convenient for collection and is less expensive than a vaginal swab placed in a transport medium.
The aim of our study is to assess the performance of self-obtained v-DRY versus "standard" v-STM and its acceptability.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV Dry first | Experimental | Other: Compare different self-obtained specimen for HPV identificationRandomization will determine the sequence of the two tests, avoiding potential bias that may advantage the "first" test. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic tests |
| HPV standard transport medium | Experimental | Other: Compare different self-obtained specimen for HPV identificationRandomization will determine the sequence of the two tests, avoiding potential bias that may advantage the "first" test. All specimens will be tested for the same pathogens (HR-HPV) using the same diagnostic tests |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 years or older,
- First consultation in our colposcopy unit,
- Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF).
Key exclusion criteria (4 listed)
- Previous hysterectomy,
- Pregnant,
- Virgin,
- Not able to comply with the protocol study.
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 |
|---|---|---|
| Compare different self-obtained specimen for HPV identificationInstructions will be given to the patients by a research nurse and ICF will be obtained. For specimen collection, participants will be instructed to wash their hands before the procedure. Each participant will receive a package containing a specimen collection kit. Recommendations will be to hold the swab by the end of the handle, to insert the swab into the vagina avoiding contact with the external genitalia, rotate 1 round and to replace the swab in a plastic sleeve (v-DRY) or in a tube containing specimen transport medium (v-STM),. | Other | HPV Dry first |
| Compare different self-obtained specimen for HPV identificationInstructions will be given to the patients by a research nurse and ICF will be obtained. For specimen collection, participants will be instructed to wash their hands before the procedure. Each participant will receive a package containing a specimen collection kit. Recommendations will be to hold the swab by the end of the handle, to insert the swab into the vagina avoiding contact with the external genitalia, rotate 1 round and to replace the swab in a plastic sleeve (v-DRY) or in a tube containing specimen transport medium (v-STM),. | Other | HPV standard transport medium |
Primary outcome
To assess sensibility and specificity of dry swabs for HPV diagnosis
Time frame: day 1
Agreement between collection methods in terms of HPV risk categories will be measured using the kappa statistic ( ) with a precision of 10% (95% confidence interval). This measure of agreement is 0 when the amount of agreement is what would be expected by chance and 1 when there is perfect agreement.
2 secondary outcomes
Preference about HPV self-collection
Time frame: day 1
Sensitivity and specificity of specimen transport medium (STM)
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2011.
- Derived from this study: PubMed 23875668Eperon I, Vassilakos P, Navarria I, Menoud PA, Gauthier A, Pache JC, Boulvain M, Untiet S, Petignat P. Randomized comparison of vaginal self-sampling by standard vs. dry swabs for human papillomavirus testing. BMC Cancer. 2013 Jul 22;13:353. doi: 10.1186/1471-2407-13-353.
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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.
Patrick Petignat, Prof study director
HUG
Questions about this trial
What is this clinical trial studying?
A study testing Compare different self-obtained specimen for HPV identification in people with Human Papillomavirus Infection, run by University Hospital, Geneva.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
To assess sensibility and specificity of dry swabs for HPV diagnosis (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316120, which also lists 1 linked publication.
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 23 Dec 2011.