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Trial registered on ANZCTR


Registration number
ACTRN12624001485527p
Ethics application status
Submitted, not yet approved
Date submitted
2/11/2024
Date registered
19/12/2024
Date last updated
19/12/2024
Date data sharing statement initially provided
19/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-Collection or Practitioner-collection Evaluation 3 to compare the clinical performance of detecting HPV associated with cervical disease
Scientific title
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
Secondary ID [1] 313297 0
None
Universal Trial Number (UTN)
U1111-1315-2723
Trial acronym
SCoPE3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cervical cancer 335634 0
HPV infection 335635 0
Cervical screening 335636 0
Cervical Intraepithelial Neoplasia 335637 0
Condition category
Condition code
Cancer 332194 332194 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329870 0
Early detection / Screening
Comparator / control treatment
The standard of care for detection of HPV as part of the Australian National Cervical Screening program was clinician-collected cervical liquid-based cytology specimens. All participants will have the clinician-collected specimen collected during the same visit (for colposcopy based on clinical referral) as the self-collected specimens.
Control group
Active

Outcomes
Primary outcome [1] 339777 0

Relative Clinical Sensitivity for HPV of self-collection specimens for the detection of cervical intraepithlial neoplasia grade 2 or above (CIN2+).
Timepoint [1] 339777 0
Single timepoint for collection for self- and clinician-collected specimens
Primary outcome [2] 339778 0
Relative Clinical Specificity for HPV of self-collection specimens for the detection of CIN2+
Timepoint [2] 339778 0

Single sample collection timepoint
Secondary outcome [1] 441270 0
Positive Predictive Agreement (PPA)
Timepoint [1] 441270 0
Single sample collection timepoint
Secondary outcome [2] 441271 0
HPV positivity
Timepoint [2] 441271 0
Single sample collection timepoint
Secondary outcome [3] 441272 0

Absolute Clinical Sensitivity for HPV of self-collection specimens for the detection of CIN2+
Timepoint [3] 441272 0
Single sample collection timepoint
Secondary outcome [4] 441273 0

Absolute Clinical Specificity for HPV of self-collection specimens for the detection of CIN2+ (the outcome from colposcopic asssessment) will be assessed.
Timepoint [4] 441273 0
Single sample collection timepoint

Eligibility
Key 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
Minimum age
25 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
13/10/2025
Actual
Date of last data collection
Anticipated
13/10/2025
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317747 0
Commercial sector/Industry
Name [1] 317747 0
Abbott Molecular Inc.
Country [1] 317747 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Centre for the Prevention of Cervical Cancer
Address
Country
Australia
Secondary sponsor category [1] 320064 0
None
Name [1] 320064 0
Address [1] 320064 0
Country [1] 320064 0
Other collaborator category [1] 283274 0
Hospital
Name [1] 283274 0
Royal Women's Hospital, Victoria
Address [1] 283274 0
Country [1] 283274 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316434 0
Royal Melbourne Hospital HREC
Ethics committee address [1] 316434 0
Ethics committee country [1] 316434 0
Australia
Date submitted for ethics approval [1] 316434 0
27/11/2024
Approval date [1] 316434 0
Ethics approval number [1] 316434 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137886 0
A/Prof Dave Hawkes
Address 137886 0
Australian Centre for the Prevention of Cervical Screening, 265 Faraday Street, Carlton, Victoria, 3053
Country 137886 0
Australia
Phone 137886 0
+61 400722202
Fax 137886 0
Email 137886 0
dhawkes@vcs.org.au
Contact person for public queries
Name 137887 0
Dave Hawkes
Address 137887 0
Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton, Victoria, 3053
Country 137887 0
Australia
Phone 137887 0
+61 400722202
Fax 137887 0
Email 137887 0
dhawkes@vcs.org.au
Contact person for scientific queries
Name 137888 0
Dave Hawkes
Address 137888 0
Australian Centre for the Prevention of Cervical Cancer, 265 Faraday Street, Carlton, Victoria, 3053
Country 137888 0
Australia
Phone 137888 0
+61 3400722202
Fax 137888 0
Email 137888 0
dhawkes@vcs.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.