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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 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.
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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.
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Secondary ID [1]
309810
0
Nil known
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Universal Trial Number (UTN)
U1111-1293-2923
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cervical cancer screening
330221
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Condition category
Condition code
Cancer
327091
327091
0
0
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
326239
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Early detection / Screening
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Comparator / control treatment
The clincian-collected LBC sample processed for HPV testing is the comparator
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
334953
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Timepoint [1]
334953
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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.
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Primary outcome [2]
335035
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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.
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Assessment method [2]
335035
0
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Timepoint [2]
335035
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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.
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Primary outcome [3]
335036
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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.
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Assessment method [3]
335036
0
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Timepoint [3]
335036
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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.
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Secondary outcome [1]
422530
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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.
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Assessment method [1]
422530
0
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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.
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Secondary outcome [2]
423793
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(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.
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Assessment method [2]
423793
0
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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.
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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.
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Assessment method [3]
423931
0
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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.
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Secondary outcome [4]
423932
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(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.
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Assessment method [4]
423932
0
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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.
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Secondary outcome [5]
423933
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(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.
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Assessment method [5]
423933
0
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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.
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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.
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Assessment method [6]
423934
0
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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.
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Secondary outcome [7]
423935
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(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.
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Assessment method [7]
423935
0
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Timepoint [7]
423935
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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.
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Eligibility
Key inclusion criteria
This is a pragmatic study and all people attending the public hospital colposcopy clinic will be invited to participate.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Those who choose not to participate or who are unable to give informed consent.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
13/02/2023
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Date of last participant enrolment
Anticipated
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Actual
28/07/2023
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Date of last data collection
Anticipated
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Actual
2/08/2023
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Sample size
Target
320
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Accrual to date
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Final
348
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Recruitment outside Australia
Country [1]
25570
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New Zealand
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State/province [1]
25570
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Waikato, Wellington, Otago
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Funding & Sponsors
Funding source category [1]
313994
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Government body
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Name [1]
313994
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National Cervical Screening Programme ( NCSP)
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Address [1]
313994
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133 Molesworth Street
Thorndon
Wellington 6011
New Zealand
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Country [1]
313994
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New Zealand
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Primary sponsor type
Government body
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Name
National Cervical Screening Programme ( NCSP)
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Address
133 Molesworth Street
Thorndon
Wellington 6011
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
315879
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None
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Name [1]
315879
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Address [1]
315879
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Country [1]
315879
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313130
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Southern Health and Disability Ethics Committees
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Ethics committee address [1]
313130
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Ministry of Health 133 Molesworth Street P.O. Box 5013 Wellington 6011 New Zealand
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Ethics committee country [1]
313130
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New Zealand
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Date submitted for ethics approval [1]
313130
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26/05/2022
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Approval date [1]
313130
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11/10/2022
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Ethics approval number [1]
313130
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2022 EXP 12827
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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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Margaret Sage
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Address
127106
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NCSP
133 Molesworth Street
Thorndon
Wellington 6011
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Country
127106
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New Zealand
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Phone
127106
0
+64 226975159
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Fax
127106
0
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Email
127106
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[email protected]
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Contact person for public queries
Name
127107
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Margaret Sage
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Address
127107
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NCSP
133 Molesworth Street
Thorndon
Wellington 6011
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Country
127107
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New Zealand
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Phone
127107
0
+64 226975159
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Fax
127107
0
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Email
127107
0
[email protected]
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Contact person for scientific queries
Name
127108
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Margaret Sage
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Address
127108
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NCSP
133 Molesworth Street
Thorndon
Wellington 6011
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Country
127108
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New Zealand
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Phone
127108
0
+64 226975159
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Fax
127108
0
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Email
127108
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19339
Study protocol
[email protected]
386012-(Uploaded-01-06-2023-15-11-55)-Study-related document.DOC
19340
Ethical approval
[email protected]
386012-(Uploaded-01-06-2023-15-11-55)-Study-related document.pdf
19341
Informed consent form
[email protected]
386012-(Uploaded-01-06-2023-15-17-46)-Study-related document.DOC
19342
Informed 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.
Download to PDF