Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs (HPVDry)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
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),.
|
|
Sperimentale: 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
|
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),.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To assess sensibility and specificity of dry swabs for HPV diagnosis
Lasso di tempo: 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.
|
day 1
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Preference about HPV self-collection
Lasso di tempo: day 1
|
Women will complete a self administered questionnaire on demographics and preference for sampling method (Dry versus standard)
|
day 1
|
|
Sensitivity and specificity of specimen transport medium (STM)
Lasso di tempo: day 1
|
Sensitivity and specificity to detect high-risk HPV using v-STM as gold standard will be reported.
|
day 1
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Patrick Petignat, Prof, HUG
Pubblicazioni e link utili
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HPVDry
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