NCT02785289

Brief Summary

The purpose of this study is to compare the performance of cotton and flocked swabs for vaginal self-sampling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

May 17, 2016

Last Update Submit

September 12, 2016

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (2)

  • Flow cytometric analysis

    Number of epithelial cells

    1 week

  • Real-time PCR analysis

    HPV positivity

    1 month

Study Arms (2)

Flocked

EXPERIMENTAL

Patients will perform vaginal cell collection beginning with the flocked swab, followed by the coton swab.

Device: Vaginal swab

Coton

EXPERIMENTAL

Patients will perform vaginal cell collection beginning with the coton swab, followed by the flocked swab.

Device: Vaginal swab

Interventions

Vaginal swabDEVICE

Vaginal cell collection will be performed with the two types of indicated swab.

CotonFlocked

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • attending the colposcopy clinic
  • accepts voluntarily to take part to the study and signs the informed consent form

You may not qualify if:

  • pregnancy
  • previous hysterectomy
  • ongoing menstruations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospitals

Geneva, Switzerland, 1205, Switzerland

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 27, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

CH(1)