Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)
18 Years
N/A
Both
Bladder Cancer
Trial Information
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Prevention
Outcome Measure:
Recurrence-free interval
Principal Investigator
K. K. Cheng, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Birmingham
Authority:
Unspecified
Study ID:
CDR0000572089
NCT ID:
NCT00553124
Start Date:
December 2005
Completion Date:
Related Keywords:
- Bladder Cancer
- stage 0 bladder cancer
- stage I bladder cancer
- stage II bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
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