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ISRCTN
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ISRCTN93864182
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ClinicalTrials.gov identifier
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Public title
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Phase II/III study to investigate the efficacy of 5-aminolaevulinic acid (ALA)-based photodynamic therapy in the treatment of Bowen's disease, actinic keratoses and study the effect of dose fractionation for superficial basal cell carcinomas
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0436118001
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Study hypothesis
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To continue to investigate the efficacy of ALA-based photodynamic therapy in the treatment of Bowen's disease and actinic keratoses. To study the effect of dose fractionation for superficial basal cell carcinomas using a randomised trial.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised active controlled parallel group trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Bowen's disease
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Participants - inclusion criteria
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Recruited from clinical oncology consultants to whom patients are referred at a district general hospital. Also direct from consultant dermatologists/plastic surgeons in Leeds and Airedale.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/02/2002
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Anticipated end date
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01/02/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Controlled trial without randomisation; Randomised controlled trial, Random allocation to:
1 Standard photodynamic therapy for superficial basal cell carcinoma
2 Dose fractionated photodynamic therapy
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Primary outcome measure(s)
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Complete remission of skin tumour and future recurrence.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Leeds Teaching Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
F
Roberts
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Address
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Clinical Oncology
Cookridge Hospital
Hospital Lane
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City/town
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Leeds
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Zip/Postcode
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LS16 6QB
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Country
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United Kingdom
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Tel
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+44 (0)113 392 4253
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Fax
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+44 (0)113 392 4214
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Email
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comdhfo@stjames.leeds.ac.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)207 307 2622
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Fax
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+44 (0)207 307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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12/08/2009
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Date ISRCTN assigned
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12/09/2003
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