Text Size

Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs (HPVDry)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Isabelle Eperon, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01316120
First received: March 15, 2011
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Human Papillomavirus Infection
 Other: Compare different self-obtained specimen for HPV identification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • To assess sensibility and specificity of dry swabs for HPV diagnosis [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Preference about HPV self-collection [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Women will complete a self administered questionnaire on demographics and preference for sampling method (Dry versus standard)

  • Sensitivity and specificity of specimen transport medium (STM) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Sensitivity and specificity to detect high-risk HPV using v-STM as gold standard will be reported.


Estimated Enrollment: 120
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPV Dry first
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
 Other: Compare different self-obtained specimen for HPV identification
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),.
Experimental: HPV standard transport medium
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
 Other: Compare different self-obtained specimen for HPV identification
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),.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Previous hysterectomy,
  • Pregnant,
  • Virgin,
  • Not able to comply with the protocol study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316120

Sponsors and Collaborators
University Hospital, Geneva
Investigators
Study Director: Patrick Petignat, Prof HUG
  More Information

No publications provided

Responsible Party: Isabelle Eperon, medical doctor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01316120     History of Changes
Other Study ID Numbers: HPVDry
Study First Received: March 15, 2011
Last Updated: December 22, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Self-collected vaginal samples
HPV
HPV self-obtained sample
HPV specimen transport medium

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
 Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013