Clinical trial NCT01316120: Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs
Official title: Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Human Papillomavirus Infection
Keywords: Self-collected vaginal samples
HPV
HPV self-obtained sample
HPV specimen transport medium
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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 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.

Primary outcomes:
measure: To assess sensibility and specificity of dry swabs for HPV diagnosis
timeFrame: day 1
Secondary outcomes:
measure: Preference about HPV self-collection
timeFrame: day 1
measure: Sensitivity and specificity of specimen transport medium (STM)
timeFrame: day 1
Other outcomes:
Locations:
Study officials:
affiliation: HUG
name: Patrick Petignat, Prof
role: STUDY_DIRECTOR
References:
citation: 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.