Skip to content

Self-Collection or Practitioner-collection Evaluation 3 to compare the clinical performance of detecting HPV associated with cervical disease

Self-Collection or Practitioner-collection Evaluation 3 to compare the clinical performance of detecting HPV associated with cervical disease in a HPV-based cervical screening referral population

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001485527
Acronym
SCoPE3
Enrollment
450
Registered
2024-12-19
Start date
2025-01-13
Completion date
2025-10-13
Last updated
2025-01-06

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

Conditions

None listed

Brief summary

This study aims to assess whether vaginal swabs self-collected using the Abbott simpli-COLLECT kit and self-collected urine samples using the Novosanis Colli-pee device have similar clinical performance detecting HPV associated with cervical disease, compared with the reference practitioner-collected cervical samples. Who is it for? You may be eligible to participate in this study if you are a female aged 25 or above, and has colposcopy referral based on abnormal result of a test within the cervical screening program.. Study details All participants in this study will attend a single clinical appointment, during which time they will be asked to take two self-collected samples, one using a swab to collect a vaginal sample, and the other being a urine sample, 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. It is hoped that the results from this study will identify a new option for people wanting to participate in cervical screening.

Interventions

The study will ask participants to take two self-collected samples, one using a swab to collect a vaginal sample, and the other being a urine sample, 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. Participants who have been referred to colposcopy would not be routinely tested for HPV as this is a ri

The study will ask participants to take two self-collected samples, one using a swab to collect a vaginal sample, and the other being a urine sample, 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. Participants 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 Abbott simpli-COLLECT kit and the Novosanis Colli-pee device. The simpli-COLLECT swab is identical to swabs used for self-collection of vaginal samples for testing for sexually transmitted infections. The Colli-pee is a device which allows the collection of a specific volume of the first pass urine and has been validated for self-collection of urine for HPV testing in other studies. Both self-collection samples 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 . Adherence to correct use of either the Colli-pee or simpli-COLLLECT devices will be determined by the presence of clinical material. The collection of urine into the Colli-pee will be visible by the increase in volume in the device. The Abbott Alinity m HPV assay will also detected whether sufficient human cellular material is present to determine if a valid clincal sample has been collected. Valid sample rates for both devices will be assessed and reported.

Sponsors

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

Study design

Allocation
Non-randomised trial
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- have a cervix - are willing and able to provide informed consent - are willing and able to self-collect two samples, one vaginal swab, one urine sample - Is willing and able to allow collection of a practitioner-collected (cervical) specimen - Has had a colposcopy referral based on an abnormal result of routine cervical screening that included HPV testing (HPV primary screening or co-testing) performed within 24 weeks preceding the colposcopy visit (either abnormal cytology, or HPV positive test result, or both) - is willing and able to undergo colposcopy and biopsy as needed

Exclusion criteria

- are unable or unwilling to provide informed consent - are unable to read and comprehend project study instructions - unable or unwilling to provide self-collected samples - have voided urine with one hour prior to urine specimen collection - has had a complete or partial hysterectomy - has a known history of excisional or ablative therapy (e.g., LEEP, cone biopsy, cervical laser surgery, or cryotherapy) to the cervix in the 12 months prior to the screening visit - is currently participating, or recently (within 6 months) participated in any trial for cervical cancer or HPV diagnostics - is currently participating or planning to participate in any clinical trial for HPV treatment - Is already a participant in this research project

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026