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

NCT01316120 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-12-23

No results posted yet for this study

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.

Conditions

  • Human Papillomavirus Infection

Interventions

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),.

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),.

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Patrick Petignat, Prof · HUG

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-08-31
Completion
2011-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01316120 on ClinicalTrials.gov