Bladder Cancer
Conditions
Keywords
stage 0 bladder cancer, stage I bladder cancer, stage II bladder cancer, transitional cell carcinoma of the bladder
Brief summary
RATIONALE: Studying different factors that effect patients with newly diagnosed bladder cancer may help doctors learn more about the disease, improve the ability to plan cancer treatment, and help patients live more comfortably. PURPOSE: This clinical trial is studying different factors affecting patients with newly diagnosed bladder cancer.
Detailed description
OBJECTIVES: * To assess the effect of lifestyle factors (e.g., smoking, dietary habits, fluid intake, or environmental exposures) on the recurrence and progression of bladder cancer. * To assess the impact of selenium and/or vitamin E on the progression and recurrence of bladder cancer. * To study health-related quality of life and its association with recurrence and progression of bladder cancer. * To establish a bladder cancer tissue bank that will comprise blood, urine, and bladder tissue. * To study the predictive effect of molecular markers on the recurrence and progression of bladder cancer. OUTLINE: This is a multicenter study. The study will be based on a cohort of patients with newly detected bladder cancer in all 16 urological centres within the West Midlands, commencing in late 2005 for a period of 5 years. This research project consists of 5 individual studies: CRUK-BCPP-2005-01-COHORT, CRUK-BCPP-2005-01-MARKERS, CRUK-BCPP-2005-01-QOL, CRUK-BCPP-2005-01-TISSUE-BANK, and CRUK-BCPP-2005-01-TREATMENT. Patients may participate in all or only some of these individual studies. Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Interventions
DRUGselenium
DRUGvitamin E
PROCEDUREbiopsy
PROCEDUREchemoprevention
PROCEDUREcryopreservation
PROCEDUREcytology specimen collection procedure
PROCEDUREdiagnostic procedure
PROCEDUREgene expression analysis
PROCEDUREimmunohistochemistry staining method
PROCEDURElaboratory biomarker analysis
PROCEDUREmedical chart review
PROCEDUREmutation analysis
PROCEDUREpolymerase chain reaction
PROCEDUREquality-of-life assessment
PROCEDUREquestionnaire administration
PROCEDUREstudy of socioeconomic and demographic variables
Sponsors
University Hospital Birmingham
Study design
Primary purpose
PREVENTION
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma meeting 1 of the following criteria: * Non-muscle-invasive tumor * Muscle-invasive tumor * Solitary G1 pTa tumor * No previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis PATIENT CHARACTERISTICS: * Fit for cystoscopy and surgical biopsy/resection * No HIV infection * No condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the study objectives PRIOR CONCURRENT THERAPY: * Not specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free interval | — |
| Progression-free interval | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of all other malignancies clinically diagnosed | — |
| Overall survival time | — |
| Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires | — |
| Incidence of cardiovascular events | — |
| Incidence of transitional cell carcinoma outside the bladder | — |
Countries
United Kingdom
Outcome results
None listed