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dc.contributor.authorTandogdu, Z
dc.contributor.authorLewis, R
dc.contributor.authorDuncan, A
dc.contributor.authorPenegar, S
dc.contributor.authorMcDonald, A
dc.contributor.authorVale, L
dc.contributor.authorShen, J
dc.contributor.authorKelly, JD
dc.contributor.authorPickard, R
dc.contributor.authorN Dow, J
dc.contributor.authorRamsay, C
dc.contributor.authorMostafid, H
dc.contributor.authorMariappan, P
dc.contributor.authorNabi, G
dc.contributor.authorCreswell, J
dc.contributor.authorLazarowicz, H
dc.contributor.authorMcGrath, J
dc.contributor.authorTaylor, E
dc.contributor.authorClark, E
dc.contributor.authorMaclennan, G
dc.contributor.authorNorrie, J
dc.contributor.authorHall, E
dc.contributor.authorHeer, R
dc.contributor.authorPHOTO Trial Management Group
dc.date.accessioned2019-05-30T13:46:08Z
dc.date.issued2019-09-03
dc.identifier.citationBMJ open, 2019, 9 (9), pp. e022268 - ?
dc.identifier.issn2044-6055
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3247
dc.identifier.eissn2044-6055
dc.identifier.doi10.1136/bmjopen-2018-022268
dc.description.abstractIntroduction Bladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective.Methods and analysis PHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients' lifetime.Ethics and dissemination Formal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration number ISRCTN84013636.
dc.formatElectronic
dc.format.extente022268 - ?
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectPHOTO Trial Management Group
dc.subjectHumans
dc.subjectNeoplasm Recurrence, Local
dc.subjectPhotosensitizing Agents
dc.subjectDiagnostic Techniques, Urological
dc.subjectTreatment Outcome
dc.subjectCystectomy
dc.subjectHealth Care Costs
dc.subjectState Medicine
dc.subjectUrinary Bladder
dc.subjectUrinary Bladder Neoplasms
dc.subjectUnited Kingdom
dc.titlePhotodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness.
dc.typeJournal Article
dcterms.dateAccepted2019-03-25
rioxxterms.versionofrecord10.1136/bmjopen-2018-022268
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2019-09-03
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfBMJ open
pubs.issue9
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/ICR-CTSU Urology and Head and Neck Trials Team
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/ICR-CTSU Urology and Head and Neck Trials Team
pubs.publication-statusPublished
pubs.volume9
pubs.embargo.termsNot known
icr.researchteamClinical Trials & Statistics Uniten_US
icr.researchteamICR-CTSU Urology and Head and Neck Trials Teamen_US
dc.contributor.icrauthorPenegar, Stevenen
dc.contributor.icrauthorHall, Emmaen
dc.contributor.icrauthorLewis, Rebeccaen


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