Validation of the dry Evalyn Brush, an improved cervicovaginal self-sampling device for HPV detection

Validation of the dry Evalyn Brush, an improved cervicovaginal self-sampling device for HPV detection - Validation dry Evalyn Brush

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35865

Enrollment

2000

Registered

2012-10-12

Start date

2013-04-11

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer human papillomavirus

Interventions

All women are asked to self-collect a cervicovaginal sample with the Evalyn Brush for determination of HPV before the regular cervical smear.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women invited by the national screening program for cervical cancer. Signed informed consent. Age 30-60 years. Mentally capable to understand and comprehend the study and its implications.

Exclusion criteria

Exclusion criteria: Women with mental impairment. No signed informed consent. Age 60 years. No sufficient knowledge of the Dutch language to understand the implications of the study, and to answer the questionnaire.

Design outcomes

Primary

Measure	Time frame
The main study parameters are measuring the overall hr-HPV agreement between self-sampled cervicovaginal smear (Evalyn Brush) and physician-obtained samples taken by a trained physician (liquid based cervical smear).	—

Secondary

Measure	Time frame
To determine the acceptability of the self-sample test.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)