Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000962639
Ethics application status
Approved
Date submitted
1/06/2023
Date registered
5/09/2023
Date last updated
5/09/2023
Date data sharing statement initially provided
5/09/2023
Date results information initially provided
5/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Human Papillomavirus (HPV) Technology Validation Study for the the ABBOTT Alinity HPV testing platform comparing the accuracy of HPV testing using a self-collected swab sample, with using a sample taken by a clinician using a liquid-based cytology sample, for adult participants undergoing cervical cancer screening in New Zealand.
Scientific title
Human Papillomavirus (HPV) Technology Validation Study for the ABBOTT Alinity HPV testing platform comparing the accuracy of HPV testing using a self-collected swab sample, with using a sample taken by a clinician using a liquid-based cytology sample, for adult participants undergoing cervical cancer screening in New Zealand.
Secondary ID [1] 309810 0
Nil known
Universal Trial Number (UTN)
U1111-1293-2923
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer screening 330221 0
Condition category
Condition code
Cancer 327091 327091 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of HPV test results between samples taken using a vaginal swab and a clinician-collected liquid-based cytology (LBC) sample. Instructions provided to participants about how to collect a self-sample have been supplied to this study with permission to use, by Professor Marion Saville, Executive Director, Australian Centre for the Prevention of Cervical Cancer. The instructions have already been used in analogous trials in Australia.
A vaginal swab sample will be self-collected by people who are about to have a colposcopy. It is anticipated that the consent process will take 10-15 minutes of in-clinic time as the Participant Information will be sent to potential participants prior to their attendance at the clinic. The time taken to collect the self-sample will be about 1 minute. The sample will be taken while the person is getting changed for their colposcopy. The colposcopist will then take a second clinician-collected LBC sample. The additional time taken to collect the clinician-taken sample will also be about 1 minute, given that the person will already be having a colposcopy independently to the study. Both samples will be tested for high-risk HPV. The samples will be processed using the ABBOTT Alinity HPV testing platform. A copy of the consent form will be sent to the laboratory with the samples and will be securely stored in the laboratory. The consent forms will only be accessible to those directly involved in the study. A specific laboratory request form has been developed for the project so that this is clear when the samples arrive in the laboratory. The clinician-collected samples are part of regular clinical services and the collection and processing of these samples in parallel with the self-collected samples, provide documentation and quality assurance processes for those participating in the study because all cases will be recorded in colposcopy and laboratory databases and will be subject to usual quality considerations in terms of accuracy of patient identification, sample identification and security of reporting results. There will be a trial investigator at each of three colposcopy site providing samples, who will be responsible for ensuring that all staff involved in the study are aware of their roles and responsibilities for conducting the study and there will be a laboratory scientist at the laboratory who will be responsible for ensuring that any staff involved in processing or reporting the trial results, know about the trial and their role in it. Trial data will be collated in the laboratory where processing occurs. There is a specific process to manage any discordant results between the two sample types, in a clinically-safe manner. This has been agreed with the colposcopists participating in the sample collection. The swab-collected HPV test result will be compared with the clinician-collected HPV test result to determine whether the swab-collected samples achieve acceptable levels of sensitivity and specificity in order to validate the use of swab-collected samples for HPV testing. Participants will be provided with a consent form, instructions about how to take a self-sample and the swab to use. Sample collection will occur at three colposcopy clinics in New Zealand, with all samples analysed at the same laboratory where the HPV test technology is being validated for swab collection. The colposcopy staff are already experienced at taking clinician-taken samples at colposcopy. The clinic will be provided with the consent form, a laboratory request form, the SurePath vials needed for the clinician-collected samples and the swabs needed for the swab-collected samples, as well as instructions to give participants about how to take their self-collected swab-sample.
Consent forms will be sent to prospective participants with their colposcopy clinic appointment to give them time to consider participation before they arrive at the colposcopy clinic. There is no other engagement with participants after their colposcopy visit. They will have access to their results and a summary of the trial, should they request these.
Intervention code [1] 326239 0
Early detection / Screening
Comparator / control treatment
The clincian-collected LBC sample processed for HPV testing is the comparator
Control group
Active

Outcomes
Primary outcome [1] 334953 0
The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the sensitivity with 95% Wilson score binomial confidence intervals for detecting HPV16. Validation of the self-collection method will be achieved by comparing the sensitivity of detection of HPV16 with the sensitivity of the clinician-collected samples for HPV16.
Timepoint [1] 334953 0
In the trial, 320 paired samples will be tested, collected at three colposcopy clinics. The trial is estimated to take up to 7 months to collect the samples with a further month for the analysis of results.
Primary outcome [2] 335035 0
The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the specificity with 95% Wilson score binomial confidence intervals for detecting HPV16. Validation of the self-collection method will be achieved by comparing the specificity of detection of HPV16 with the specificity of the clinician-collected samples for HPV16.
Timepoint [2] 335035 0
Data will be analysed once at least 320 paired samples have been tested. The trial is estimated to take up to 7 months with a further month for the analysis of results.
Primary outcome [3] 335036 0
The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the observed agreement with 95% Wilson score binomial confidence intervals for detecting HPV16.
Timepoint [3] 335036 0
Data will be analysed once at least 320 paired samples have been tested. The trial is estimated to take up to 7 months with a further month for the analysis of results.
Secondary outcome [1] 422530 0
We will also estimate the sensitivity of self- and clinician-collected samples where any positive result from either sampling method is indicative of infection. This is a composite measure.
The overall level of agreement will also be assessed by calculating Gwet’s AC1 coefficient for interrater agreement.
Timepoint [1] 422530 0
Data will be analysed once at least 320 paired samples have been tested. The trial is estimated to take up to 7 months with a further month for the analysis of results.
Secondary outcome [2] 423793 0
(This is a primary outcome). The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the sensitivity with 95% Wilson score binomial confidence intervals for detecting HPV18. Validation of the self-collection method will be achieved by comparing the sensitivity of detection of HPV18 with the sensitivity of the clinician-collected samples for HPV18.
Timepoint [2] 423793 0
Data will be analysed once at least 320 paired samples have been tested. The trial is estimated to take up to 7 months with a further month for the analysis of results.
Secondary outcome [3] 423931 0
(This is a primary outcome). The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the specificity with 95% Wilson score binomial confidence intervals for detecting HPV18. Validation of the self-collection method will be achieved by comparing the specificity of detection of HPV18 with the specificity of the clinician-collected samples for HPV18.
Timepoint [3] 423931 0
Data will be analysed once at least 320 paired samples have been tested. The trial is estimated to take up to 7 months with a further month for the analysis of results.
Secondary outcome [4] 423932 0
(This is a primary outcome).The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the observed agreement with 95% Wilson score binomial confidence intervals for detecting HPV18.
Timepoint [4] 423932 0
Data will be analysed once at least 320 paired samples have been tested. The trial is estimated to take up to 7 months with a further month for the analysis of results.
Secondary outcome [5] 423933 0
(This is a primary outcome). The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the sensitivity with 95% Wilson score binomial confidence intervals for detecting Other oncogenic HPV (non-HPV 16/18) i.e. HPV31/33/35/39/45/51/52/56/58/59/66/68. Validation of the self-collection method will be achieved by comparing the sensitivity of detection of HPV Other oncogenic types with the sensitivity of the clinician-collected samples for HPV Other oncogenic types.
Timepoint [5] 423933 0
Data will be analysed once at least 320 paired samples have been tested. The trial is estimated to take up to 7 months with a further month for the analysis of results.
Secondary outcome [6] 423934 0
(This is a primary outcome). The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the specificity with 95% Wilson score binomial confidence intervals for detecting Other oncogenic HPV (non-HPV 16/18) i.e. HPV31/33/35/39/45/51/52/56/58/59/66/68. Validation of the self-collection method will be achieved by comparing the specificity of detection of HPV Other oncogenic types with the specificity of the clinician-collected samples for HPV Other oncogenic types.
Timepoint [6] 423934 0
Data will be analysed once at least 320 paired samples have been tested. The trial is estimated to take up to 7 months with a further month for the analysis of results.
Secondary outcome [7] 423935 0
(This is a primary outcome). The accuracy of test results from valid self-collected samples will be compared with test results from paired valid clinician-taken samples by calculating the observed agreement with 95% Wilson score binomial confidence intervals for detecting Other oncogenic HPV (non-HPV 16/18) i.e. HPV31/33/35/39/45/51/52/56/58/59/66/68.
Timepoint [7] 423935 0
Data will be analysed once at least 320 paired samples have been tested. The trial is estimated to take up to 7 months with a further month for the analysis of results.

Eligibility
Key inclusion criteria
This is a pragmatic study and all people attending the public hospital colposcopy clinic will be invited to participate.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who choose not to participate or who are unable to give informed consent.

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)
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
Assuming an HPV positivity rate of at least 40% in samples collected at colposcopy, a sample size of 313 will be of sufficient size to estimate test sensitivity with 95% confidence interval of no wider than plus or minus 8%. This sample size will also allow the estimation of Gwet’s AC1 coefficient with confidence intervals no wider than plus or minus 8%.
A sample size of at least 320 samples will be collected to allow for the possibility of an HPV sample which can not be analysed. For example, if an LBC vial is leaking on arrival at the laboratory (clinician-taken) the sample will not be processed because of the risk of cross-contamination. This is a mandatory requirement under the National Cervical Screening Programme Policies and Standards in New Zealand. The additional 7 paired samples being collected are to ensure that there is a minimum of 313 paired samples with results. All adequate paired samples collected will be processed and included in the final results.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/02/2023
Date of last participant enrolment
Anticipated
Actual
28/07/2023
Date of last data collection
Anticipated
Actual
2/08/2023
Sample size
Target
320
Accrual to date
Final
348
Recruitment outside Australia
Country [1] 25570 0
New Zealand
State/province [1] 25570 0
Waikato, Wellington, Otago

Funding & Sponsors
Funding source category [1] 313994 0
Government body
Name [1] 313994 0
National Cervical Screening Programme ( NCSP)
Country [1] 313994 0
New Zealand
Primary sponsor type
Government body
Name
National Cervical Screening Programme ( NCSP)
Address
133 Molesworth Street
Thorndon
Wellington 6011
New Zealand
Country
New Zealand
Secondary sponsor category [1] 315879 0
None
Name [1] 315879 0
Address [1] 315879 0
Country [1] 315879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313130 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 313130 0
Ministry of Health
133 Molesworth Street
P.O. Box 5013
Wellington 6011
New Zealand
Ethics committee country [1] 313130 0
New Zealand
Date submitted for ethics approval [1] 313130 0
26/05/2022
Approval date [1] 313130 0
11/10/2022
Ethics approval number [1] 313130 0
2022 EXP 12827

Summary
Brief summary
The study involves comparing the HPV test results taken using an HPV swab sample, with the HPV test results for a sample taken at the same time from the same person by a clinician using a liquid-based cytology sample, with both samples processed at the same laboratory using the same HPV test equipment.. Based on international trials, it is anticipated that the sensitivity of the swab collected sample to detect HPV will be comparable to the HPV test results using the clinician-collected sample. If this is demonstrated, then the swab-collected sample will be offered for use for HPV screening tests at the laboratory participating in the study, in the National Cervical Screening Programme in New Zealand
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127106 0
Dr Margaret Sage
Address 127106 0
NCSP
133 Molesworth Street
Thorndon
Wellington 6011
Country 127106 0
New Zealand
Phone 127106 0
+64 226975159
Fax 127106 0
Email 127106 0
margaret.sage@health.govt.nz
Contact person for public queries
Name 127107 0
Dr Margaret Sage
Address 127107 0
NCSP
133 Molesworth Street
Thorndon
Wellington 6011
Country 127107 0
New Zealand
Phone 127107 0
+64 226975159
Fax 127107 0
Email 127107 0
margaret.sage@health.govt.nz
Contact person for scientific queries
Name 127108 0
Dr Margaret Sage
Address 127108 0
NCSP
133 Molesworth Street
Thorndon
Wellington 6011
Country 127108 0
New Zealand
Phone 127108 0
+64 226975159
Fax 127108 0
Email 127108 0
margaret.sage@health.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will be made available to the individual participants on request but will not be publicly available for privacy reasons


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19339Study protocol  margaret.sage@health.govt.nz 386012-(Uploaded-01-06-2023-15-11-55)-Study-related document.DOC
19340Ethical approval  margaret.sage@health.govt.nz 386012-(Uploaded-01-06-2023-15-11-55)-Study-related document.pdf
19341Informed consent form  margaret.sage@health.govt.nz 386012-(Uploaded-01-06-2023-15-17-46)-Study-related document.DOC
19342Informed consent form    386012-(Uploaded-01-06-2023-15-18-27)-Study-related document.DOC



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.