Comparison of Self-Collection vs Practitioner Collection Project for HPV-based cervical screening

Quantification of sensitivity of Self-Collection vs Practitioner Collection Project for HPV-based cervical screening

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001442392

Enrollment

303

Registered

2017-10-11

Start date

2017-07-28

Completion date

2017-11-13

Last updated

2018-10-01

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

Conditions

None listed

Brief summary

The aim of this study is to compare self-collected versus practitioner collected samples for HPV-based cervical cancer screening. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above, and are attending an appointment for a colposcopic procedure. Study details All participants in this study will attend a single clinical appointment, during which time they will self-collect a vaginal sample using a dry flocked swab. Following this, a healthcare practitioner will collect a cervical sample using a cervical collection device (brush/broom). Both samples will be tested for Human Papillomavirus (HPV) nucleic acid, and the results compared. The study will also examine the rate of invalid HPV results for both the self-collected and practitioner-collected samples. This study will contribute information on the sensitivity of a self collected sample for HPV-based cervical screening and may contribute to this method being adopted as part of the new HPV-based national cervical screening program due to begin in late 2017.

Interventions

Participants will self-collect a vaginal sample following the supplied instruction sheet and using a supplied dry flocked swab, followed by a healthcare practitioner collecting a cervical sample using a cervical collection device (brush/broom) of the practitioner's choice and placing that device in a vial of collection media (PreservCyt). Both samples wil be collected within the same clinic visit before being be tested for Human Papillomavirus (HPV) nucleic acid. There is no intervention, this

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Women who are attending an appointment for a colposcopic procedure. Women who have given informed consent

Exclusion criteria

Pregnancy

Outcome results