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Comparison clinical sensitivity and specificity of self-collected vs practitioner-collected samples from patients attending for colposcopy.

Self-collection or Practitioner-collection Evaluation Project 2 for detection of Human Papillomavirus using the VALHUDES protocol

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000993695
Acronym
SCoPE2
Enrollment
400
Registered
2023-09-12
Start date
2022-04-08
Completion date
2022-11-18
Last updated
2023-09-18

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

Conditions

None listed

Brief summary

SCoPE2 is evaluating different methods of self-collection to determine is alternative methods can be used with new HPV nucleic acid based assays to facilitate a wider range of options for HPV-based cervical screening. There is a lot of evidence demonstrating that self-collection is as good as clinician-collected for HPV-based cervical screening. SCoPE2 is looking to assess whether the method in this study produces similar results showing that self-collection is equivalent to clinician-collected samples for HPV-based cervical screening.

Interventions

The study will ask participants to take two self-collected vaginal samples using two different devices and compare them against the standard of care clinician-collected specimen from the cervix for the detection of Human Papillomavirus (HPV) using any colposcopy biopsy findings as the reference for sensitivity and specificity for cervical disease. Particiapnts who have been referred to colposcopy would not be routinely tested for HPV as this is a risk stratification rather than diagnostic test.

The study will ask participants to take two self-collected vaginal samples using two different devices and compare them against the standard of care clinician-collected specimen from the cervix for the detection of Human Papillomavirus (HPV) using any colposcopy biopsy findings as the reference for sensitivity and specificity for cervical disease. Particiapnts who have been referred to colposcopy would not be routinely tested for HPV as this is a risk stratification rather than diagnostic test. The two devices are the Copan FLOQSwab and the Rovers Viba-brush. The Copan FLOQSwab is a thin swab (similar to the swabs used for collection of a sample for COVID19 PCR testing. The Viba-brush is a simpler version of the Evalyn brush which is a device designed specifically for self-collection for HPV-based cervical screening and consists of a head with a soft plastic broom-like head on a plastic shaft. Both are commonly used in self-collection and have regulatory approval for self-collection for HPV-based cervical screening and collection would take less than one minute for each device. Both devices will be collected at the same time in a private space while waiting for the patient's colposcopy appointment, Collection with both devices would be completed is less than five minutes total time .

Sponsors

Australian Centre for the Prevention of Cervical Cancer
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Over 18 years of age, attending colposcopy clinic, gave informed consent

Exclusion criteria

Pregnancy, unable to give informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026