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

20 Years
Open (Enrolling by invite only)
Human Papillomavirus Infection

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To assess sensibility and specificity of dry swabs for HPV diagnosis

Outcome Description:

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.

Outcome Time Frame:

day 1

Safety Issue:


Principal Investigator

Patrick Petignat, Prof

Investigator Role:

Study Director

Investigator Affiliation:



Switzerland: Ethikkommission

Study ID:




Start Date:

November 2010

Completion Date:

December 2011

Related Keywords:

  • Human Papillomavirus Infection
  • Self-collected vaginal samples
  • HPV
  • HPV self-obtained sample
  • HPV specimen transport medium
  • Warts
  • Papillomavirus Infections