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Recurrence and Progression of Non-Muscle-Invasive Bladder Cancer

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Recurrence and Progression of Non-Muscle-Invasive Bladder Cancer Cancer Research UK Bladder Cancer Group BLADDER CANCER PROGNOSIS PROGRAMME Incorporating ‘SELENIB’ TRIAL Protocol (BCPP 2005-01) FINAL VERSION 9.0 June 2019 PLEASE DESTROY ALL PREVIOUS DRAFTS BCPP MREC APPROVAL: 23rd November 2005 BCPP START DATE: 7th December 2005 SELENIB MREC APPROVAL: 20th September 2006 SELENIB START DATE: 17th July 2007 A programme of research Conducted by: Funded by: CONTACTS Chief Investigator BCPP Study Office Dr Richard T Bryan Ben Abbotts, Trial Co-ordinator Institute of Cancer and Genomic Sciences Room G26, Robert Aitken Building, University of Birmingham Institute of Cancer and Genomic Sciences Edgbaston University of Birmingham Birmingham B15 2TT Edgbaston Tel: 0121 414 7870 Birmingham B15 2TT Email: [email protected] Tel: 0121 415 8836 Fax: 0121 415 8837 Email: [email protected] Other Investigators Ms Sarah Pirrie Professor ND James CR UK Institute for Cancer Studies The Institute for Cancer Research University of Birmingham London Biostatistician Lead Oncologist Professor KK Cheng Department of Public Health, Epidemiology, and Biostatistics University of Birmingham Dr N Deshmukh University Hospital Birmingham NHS Foundation Trust Pathologist Mr P Patel University Hospital Birmingham NHS Foundation Trust Lead Urologist Professor MP Zeegers NUTRIM School of Nutrition and Translational Research in Metabolism Maastricht University Medical Centre The Netherlands Genetic Epidemiologist Bladder Cancer Prognosis Programme Protocol, FINAL VERSION 9.0 June 2019 2 TABLE OF CONTENTS SECTION 1: INTRODUCTION AND STUDY SUMMARY ................................................... 9 1.1. PROGRAMME BACKGROUND ........................................................................................ 9 1.2. PROGRAMME OVERVIEW ........................................................................................... 10 SECTION 2: PROJECT A1: LONGITUDINAL COHORT STUDY OF DIETARY, LIFESTYLE AND ENVIRONMENTAL FACTORS ........................................................... 13 2.1. BACKGROUND ........................................................................................................... 13 2.1.1. Smoking.......................................................................................................... 13 2.1.2. Diet ................................................................................................................. 14 2.1.3. Total fluid intake .............................................................................................. 15 2.1.4. Alcohol drinking .............................................................................................. 15 2.1.5. Coffee drinking................................................................................................ 15 2.1.6. Tea drinking .................................................................................................... 16 2.1.7. Artificial sweeteners ........................................................................................ 16 2.1.8. Medication ...................................................................................................... 16 2.1.9. Occupational Exposures ................................................................................. 17 2.1.10. Environmental exposures ............................................................................... 17 2.1.11. Radiation ........................................................................................................ 18 2.1.12. Urine pH ......................................................................................................... 18 2.1.13. Menstrual, reproductive, and hormonal factors ............................................... 18 2.1.14. Familial history of bladder cancer.................................................................... 18 2.1.15. Hair dyes ........................................................................................................ 18 2.2. OBJECTIVE ............................................................................................................... 19 2.3. RESEARCH QUESTIONS ............................................................................................. 19 2.3.1. Primary research questions ............................................................................ 19 2.3.2. Exploratory research questions ....................................................................... 20 2.4. METHODS ................................................................................................................. 20 2.4.1. Study design ................................................................................................... 20 2.4.2. Setting ............................................................................................................ 20 2.4.3. Study population ............................................................................................. 21 2.4.4. Recruitment of the cohort ................................................................................ 21 2.4.5. Inclusion / Exclusion Criteria ........................................................................... 21 2.4.6. Patient identification, recruitment and consent process ................................... 22 2.5. DATA COLLECTION..................................................................................................... 22 2.5.1. Baseline data collection .................................................................................. 22 2.5.2. Postal questionnaire and diary ........................................................................ 23 2.5.3. Follow-up ........................................................................................................ 23 2.5.3.1. Post TURBT and annual follow-up data collection ........................................................ 23 2.5.4. Follow-up after recurrence or progression ....................................................... 24 2.5.5. Central pathological review ............................................................................. 24 2.6. STATISTICAL CONSIDERATIONS .................................................................................. 24 2.6.1. Primary Outcomes .......................................................................................... 24 2.6.2. Main statistical analysis .................................................................................. 25 2.6.3. Sample size and statistical power ................................................................... 25 Bladder Cancer Prognosis Programme Protocol, FINAL VERSION 9.0 June 2019 3 SECTION 3: PROJECT A2: ‘SELENIB’ TRIAL............................................................... 26 3.1. TRIAL SUMMARY ....................................................................................................... 26 3.2. BACKGROUND ........................................................................................................... 26 3.2.1. Evidence to justify the choice of interventions tested - selenium ..................... 26 3.2.1.1. Laboratory studies ......................................................................................................... 26 3.2.1.2. Prospective cohort studies ............................................................................................ 27 3.2.1.3. Intervention studies ....................................................................................................... 27 3.2.2. Evidence to justify the choice of interventions tested – Vitamin E ................... 28 3.2.2.1. Laboratory studies ......................................................................................................... 28 3.2.2.2. Prospective cohort studies ............................................................................................ 28 3.2.2.3. Intervention studies ....................................................................................................... 29 3.2.3. Significance of the SELENIB trial .................................................................... 30 3.3. OBJECTIVE ............................................................................................................... 31 3.4. METHODS ................................................................................................................. 31 3.4.1. Trial design ..................................................................................................... 31 3.4.2. Trial population ............................................................................................... 31 3.4.3. Patient recruitment .......................................................................................... 31 3.4.4. Eligibility criteria .............................................................................................. 32 3.4.4.1. Inclusion criteria ............................................................................................................ 32 3.4.4.2. Exclusion criteria ........................................................................................................... 32 3.4.5. Patient identification, recruitment and consent process ................................... 32 3.4.6. Randomisation ................................................................................................ 33 3.4.6.1. Stratification ................................................................................................................... 33 3.4.6.2. Allocation of Treatment ................................................................................................
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