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Trial registered on ANZCTR


Registration number
ACTRN12623000993695
Ethics application status
Approved
Date submitted
21/08/2023
Date registered
12/09/2023
Date last updated
12/09/2023
Date data sharing statement initially provided
12/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison clinical sensitivity and specificity of self-collected vs practitioner-collected samples from patients attending for colposcopy.
Scientific title
Self-collection or Practitioner-collection Evaluation Project 2 for detection of Human Papillomavirus using the VALHUDES protocol
Secondary ID [1] 310428 0
Nil known
Universal Trial Number (UTN)
U1111-1296-9251
Trial acronym
SCoPE2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer 331196 0
HPV Infection 331197 0
Cervical Screening 331198 0
Cervical Intraepithelial Neolasia 331200 0
Condition category
Condition code
Cancer 327972 327972 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 .
Intervention code [1] 326828 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] 335825 0
Relative Clinical Sensitivity for HPV of self-collection specimens for the detection of cervical intraepithlial neoplasia grade 2 or above (CIN2+) will be assessed by comparison with clinician-collected cervical specimens in liquid-based cytology media.
Timepoint [1] 335825 0
Single timepoint for collection for self- and clinician-collected specimens
Primary outcome [2] 335928 0
Relative Clinical Specificity for HPV of self-collection specimens for the detection of CIN2+ will be assessed by comparison with clinician-collected cervical specimens in liquid-based cytology media.
Timepoint [2] 335928 0
Single timepoint for collection for self- and clinician-collected specimens.
Secondary outcome [1] 425810 0
Absolute Clinical Sensitivity for HPV of self-collection specimens for the detection of CIN2+ (the outcome from colposcopic asssessment) will be assessed. This secondary outcome is related to the first Primary Outcome which assesses the clinical sensitivity against the current gold standard for detection of CIN2+ using HPV which is the clinician-collected cervical specimen ('Relative sensitivity'). This secondary outcome looks simply at how sensitive self-collection is for CIN2+ without reference to any other test.
Timepoint [1] 425810 0
Single sample collection timepoint
Secondary outcome [2] 426165 0
Absolute Clinical Specificity for HPV of self-collection specimens for the detection of CIN2+ (the outcome from colposcopic asssessment) will be assessed. This secondary outcome is related to the second Primary Outcome which assesses the clinical specificity against the current gold standard for specificity for CIN2+ using HPV which is the clinician-collected cervical specimen ('Relative specificity'). This secondary outcome looks simply at how specific self-collection is for CIN2+ without reference to any other test.
Timepoint [2] 426165 0
Single sample collection timepoint

Eligibility
Key inclusion criteria
Over 18 years of age, attending colposcopy clinic, gave informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, unable to give informed consent

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sensitivity and specificity will be calculated against histologically confirmed CIN2+. 95% confidence intervals will also be calculated. Relative sensitivity and specificity against the HPV detection from the clinician-collected specimen will be calculated. Relative Sensitivity and specificity will be assessed against the published VALHUDES protocol with proposed thresholds of 90% and 95% respectively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/04/2022
Date of last participant enrolment
Anticipated
Actual
18/11/2022
Date of last data collection
Anticipated
Actual
18/05/2023
Sample size
Target
400
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25422 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 41164 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 314636 0
Charities/Societies/Foundations
Name [1] 314636 0
Australian Centre for the Prevention of Cervical Cancer
Country [1] 314636 0
Australia
Funding source category [2] 314705 0
Government body
Name [2] 314705 0
Australian Department of Health and Aging
Country [2] 314705 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Centre for the Prevention of Cervical Cancer
Address
265 Faraday Street, Carlton, Victoria, 3053
Country
Australia
Secondary sponsor category [1] 316599 0
None
Name [1] 316599 0
Address [1] 316599 0
Country [1] 316599 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313657 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 313657 0
Ethics committee country [1] 313657 0
Australia
Date submitted for ethics approval [1] 313657 0
08/12/2021
Approval date [1] 313657 0
20/12/2021
Ethics approval number [1] 313657 0
HREC/79831/RWH-21-57

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

Contacts
Principal investigator
Name 128906 0
Prof Marion Saville
Address 128906 0
Australian Centre for the Prevention of Cervical Cancer265 Faraday Street, Carlton, Victoria, 3053
Country 128906 0
Australia
Phone 128906 0
+61 392500322
Fax 128906 0
Email 128906 0
[email protected]
Contact person for public queries
Name 128907 0
Dave Hawkes
Address 128907 0
Australian Centre for the Prevention of Cervical Cancer265 Faraday Street, Carlton, Victoria, 3053
Country 128907 0
Australia
Phone 128907 0
+61 392500300
Fax 128907 0
Email 128907 0
[email protected]
Contact person for scientific queries
Name 128908 0
Dave Hawkes
Address 128908 0
Australian Centre for the Prevention of Cervical Cancer265 Faraday Street, Carlton, Victoria, 3053
Country 128908 0
Australia
Phone 128908 0
+61 392500300
Fax 128908 0
Email 128908 0
[email protected]

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.