Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001442392
Ethics application status
Approved
Date submitted
27/01/2017
Date registered
11/10/2017
Date last updated
24/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Self-Collection vs Practitioner Collection Project for HPV-based cervical screening
Scientific title
Quantification of sensitivity of Self-Collection vs Practitioner Collection Project for HPV-based cervical screening
Secondary ID [1] 291018 0
Nil known
Universal Trial Number (UTN)
U1111-1192-1490
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer Screening 301798 0
Condition category
Condition code
Cancer 301486 301486 0 0
Cervical (cervix)
Public Health 304332 304332 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 is simply about quatifying the relative sensitivity of self-collected samples compared with best practice practitioner collected samples
Intervention code [1] 296991 0
Early detection / Screening
Comparator / control treatment
Each women will supply two samples, one that was self-collected and the other which was practitioner collected. The practitioner collected specimen is the standard practice for collection of a cervical sample for HPV nucleic acid testing and will be used as the control sample
Control group
Active

Outcomes
Primary outcome [1] 300881 0
Sensitivity of self-collected vaginal samples for the detection of HPV as compared to practitioner collected samples, assessed using commercially available HPV nucleic acid assays.
Timepoint [1] 300881 0
Both samples taken at the same clinical visit
Secondary outcome [1] 331107 0
Sub-analysis will be undertaken for HPV16, HPV18, vaccine HPV types, non HPV16/18 types, non vaccine HPV types, HPV negative, and invalid results. Samples will be tested on a range of different commercially available HPV nucleic acid assays and these results from different assays will be compared.
Timepoint [1] 331107 0
All samples taken at a single clinical visit

Eligibility
Key inclusion criteria
Women who are attending an appointment for a colposcopic procedure.
Women who have given informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable - all participants collect two samples
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The self-collected sample must be collected first, followed by the practitioner collected sample.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sensitivity of HPV nucleic acid testing between the two methods of collection will be compared. Analysis will include assessing the sensitivity (with 95% CI) of the self-collected sample compared with the practitioner collected sample. Agreement in HPV detection between self-collected and practitioner-collected samples by Kappa estimates, and the prevalence of any HPV type detected by a range of HPV nucleic acid based diagnostic testing assays, as well as a sub-analysis comparing HPV16, HPV18, vaccine-associated HPV types, non-vaccine associated HPV types, non-HPV16/18 positive results, invalid and HPV negative results.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/07/2017
Date of last participant enrolment
Anticipated
30/11/2017
Actual
13/11/2017
Date of last data collection
Anticipated
30/11/2017
Actual
21/11/2017
Sample size
Target
303
Accrual to date
Final
303
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7392 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 15186 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 295447 0
Charities/Societies/Foundations
Name [1] 295447 0
Victorian Cytology Service Ltd
Country [1] 295447 0
Australia
Funding source category [2] 297713 0
Commercial sector/Industry
Name [2] 297713 0
Roche Molecular Systems
Country [2] 297713 0
United States of America
Funding source category [3] 297714 0
Commercial sector/Industry
Name [3] 297714 0
BD Australia
Country [3] 297714 0
Australia
Funding source category [4] 297715 0
Commercial sector/Industry
Name [4] 297715 0
Abbott Australia
Country [4] 297715 0
Australia
Funding source category [5] 297716 0
Commercial sector/Industry
Name [5] 297716 0
Cepheid
Country [5] 297716 0
Australia
Funding source category [6] 297717 0
Commercial sector/Industry
Name [6] 297717 0
Seegene
Country [6] 297717 0
Korea, Republic Of
Primary sponsor type
Charities/Societies/Foundations
Name
Victorian Cytology Service Ltd
Address
265 Faraday Street
Carlton
Victoria 3053
Country
Australia
Secondary sponsor category [1] 294268 0
None
Name [1] 294268 0
Address [1] 294268 0
Country [1] 294268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296779 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 296779 0
Cnr Grattan St & Flemington Rd, Parkville VIC 3052
Ethics committee country [1] 296779 0
Australia
Date submitted for ethics approval [1] 296779 0
09/05/2017
Approval date [1] 296779 0
21/07/2017
Ethics approval number [1] 296779 0
17/15

Summary
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.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 72026 0
A/Prof Marion Saville
Address 72026 0
Victorian Cytology Service Ltd
265 Faraday Street, Carlton, Victoria, 3053
Country 72026 0
Australia
Phone 72026 0
+613 9250 0300
Fax 72026 0
Email 72026 0
[email protected]
Contact person for public queries
Name 72027 0
Dr David Hawkes
Address 72027 0
Victorian Cytology Service Ltd
265 Faraday Street, Carlton, Victoria, 3053
Country 72027 0
Australia
Phone 72027 0
+613 9250 0300
Fax 72027 0
Email 72027 0
[email protected]
Contact person for scientific queries
Name 72028 0
Dr David Hawkes
Address 72028 0
Victorian Cytology Service Ltd
265 Faraday Street, Carlton, Victoria, 3053
Country 72028 0
Australia
Phone 72028 0
+613 9250 0300
Fax 72028 0
Email 72028 0
[email protected]

No information has been provided regarding IPD availability


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.