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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04571840
Registration number
NCT04571840
Ethics application status
Date submitted
9/09/2020
Date registered
1/10/2020
Titles & IDs
Public title
Prostate Imaging Using MRI +/- Contrast Enhancement
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Scientific title
A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer
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Secondary ID [1]
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135819
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Universal Trial Number (UTN)
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Trial acronym
PRIME
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Multiparametric MRI +/- prostate biopsy
Diagnosis / Prognosis - Biparametric MRI +/- prostate biopsy
Active comparator: mpMRI - Multiparametric MRI
Experimental: bpMRI - Biparametric MRI
Diagnosis / Prognosis: Multiparametric MRI +/- prostate biopsy
MRI with T2-weighted, diffusion weighted and dynamic contrast enhanced sequences followed by prostate biopsy if indicated on MRI and clinical findings
Diagnosis / Prognosis: Biparametric MRI +/- prostate biopsy
MRI with T2-weighted and diffusion weighted sequences followed by prostate biopsy if indicated on MRI and clinical findings
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of men with clinically significant cancer
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Assessment method [1]
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Timepoint [1]
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When biopsy results available, at an expected average of 30 days post-biopsy
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Secondary outcome [1]
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Proportion of men with clinically insignificant cancer (Gleason grade 3+3 / Gleason grade group 1)
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Assessment method [1]
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Timepoint [1]
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When biopsy results available, at an expected average of 30 days post-biopsy
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Secondary outcome [2]
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Agreement between bpMRI and mpMRI for score of suspicion
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Assessment method [2]
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Score of suspicion on MRI (1-5) - lowest score = 1 = highly unlikely to be significant cancer. Highest score = 5 = highly likely to be significant cancer. For MRI to be non-suspicious it needs to be scored 1 or 2 on both Likert and PIRADSv2.1 systems. For MRI to be suspicious it can to be scored 3, 4 or 5 on either Likert or PIRADSv2.1 systems.
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Timepoint [2]
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When MRI results available, at an expected average of 30 days post-MRI
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Secondary outcome [3]
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Agreement between bpMRI and mpMRI for radiological staging decision
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Assessment method [3]
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Timepoint [3]
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When MRI results available, at an expected average of 30 days post-MRI
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Secondary outcome [4]
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Agreement between bpMRI and mpMRI for treatment eligibility
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Assessment method [4]
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At the coordinating centre, in a multi-disciplinary team meeting, treatment eligibility decisions without the DCE information will be made and once the clinicians are unblinded to the DCE sequence the impact that this information makes on the treatment decision will be evaluated.
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Timepoint [4]
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When treatment options discussed in multidisciplinary meeting, at an expected average of 30 days post intervention
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Secondary outcome [5]
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Test performance characteristics for bpMRI & mpMRI when using the Likert scoring system in comparison to the PIRADS scoring system
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Assessment method [5]
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Timepoint [5]
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When biopsy results available, at an expected average of 30 days post-MRI
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Secondary outcome [6]
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Proportion of men with cancer missed by bpMRI and mpMRI-targeted biopsies and detected by systematic biopsy
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Assessment method [6]
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Timepoint [6]
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When biopsy results available, at an expected average of 30 days post-biopsy
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Secondary outcome [7]
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Cost-effectiveness of BpMRI compared to mpMRI (cost per diagnosis of prostate cancer)
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Assessment method [7]
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A within-trial analysis will be conducted to calculate the total cost for bpMRI and mpMRI and mean cost per patient if a strategy of bpMRI or mpMRI were adopted. The cost per diagnosis of clinically significant cancer will be calculated for bpMRI and mpMRI. An incremental cost effectiveness ratio may be calculated by deriving the additional cost per case of clinically significant cancer diagnosed. The cost of avoiding each additional case of clinically insignificant cancer diagnosed may also be calculated. Consideration will be given to extending this analysis using economic modelling to allow a lifetime perspective to be taken and the estimation of quality adjusted life years (QALYs). Costs of procedures will be estimated by multiplying standard unit costs by key resource using data captured within the trial. If possible, standard unit costs (e.g. NHS Reference costs) will be supplemented by unit cost data (and uncertainty around these costs) from the participating trial sites.
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Timepoint [7]
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At an expected average of 30 days post-intervention
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Eligibility
Key inclusion criteria
1. Men at least 18 years of age referred with clinical suspicion of prostate cancer
2. Serum PSA = 20ng/ml
3. Fit to undergo all procedures listed in protocol
4. Able to provide written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior prostate biopsy
2. Prior treatment for prostate cancer
3. Prior prostate MRI on a previous encounter
4. Contraindication to MRI
5. Contraindication to prostate biopsy
6. Unfit to undergo any procedures listed in protocol
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2024
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne E.
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Recruitment hospital [2]
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Monash University - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne E.
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Minnesota
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United States of America
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New York
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Argentina
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Buenos Aires
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Belgium
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Ghent
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Brazil
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São Paulo
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Canada
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Toronto
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Denmark
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Copenhagen
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Finland
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State/province [8]
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Helsinki
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France
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State/province [9]
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Bordeaux
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France
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Lille
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France
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Paris
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Germany
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Düsseldorf
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Hamburg
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Italy
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State/province [16]
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Milan
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Italy
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Rome
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Italy
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State/province [18]
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Turin
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Italy
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Udine
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Netherlands
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Nijmegen
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Singapore
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Novena
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Spain
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Córdoba
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Spain
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Madrid
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United Kingdom
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Cambridge
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
University College, London
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer. This means that we are comparing MRI scans that requires injection of IV contrast (the current standard practice) versus MRI scans that can be performed without IV contrast in the detection of prostate cancer.
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Trial website
https://clinicaltrials.gov/study/NCT04571840
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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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Veeru Kasivisvanathan, MBBS PhD
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Address
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University College, London
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Veeru Kasivisvanathan, MBBS PhD
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Address
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Country
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Phone
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0207 679 5057
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Anonymised data will be available at request for bona fide researchers with important research questions subject to approval by the study steering committee.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
Data will become available 1 year after publication of the main study results.
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Available to whom?
A study steering committee will review all requests for access to the data and will make decisions on whether or not to grant access to bona fide researchers based on the importance of the research question being asked, ensuring analysis is non overlapping with existing analyses and planned analyses.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04571840