Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [COHORT]
18 Years
N/A
Both
Bladder Cancer
Trial Information
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [COHORT]
OBJECTIVES:
- To examine if common and potentially modifiable dietary, lifestyle, and environmental
exposures affect the risk of recurrence and progression in bladder cancer.
OUTLINE: This is a multicenter study.
Detailed information will be collected about the patients' lifestyle and their exposure to
risk factors associated with bladder cancer using semi-structured questionnaires. A baseline
questionnaire will be administered at the time of diagnosis and will collect information
about socio-demographics, environmental exposures, medical history, diet, health-related
quality of life, and social support.
Further questionnaires will be administered at regular follow-up visits to capture
information relating to changes in exposure. A postal questionnaire will be used to collect
historical information that may require the patient to check records or consult family or
friends. Patients will also be asked to keep a 1-week food, fluid, and micturition diary.
Patients continue to complete questionnaires at 3 months and then annually for up to 5
years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Inclusion Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria:
- Enrolled on parent protocol CRUK-BCPP-2005-01
- Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or
transitional cell carcinoma
- Histologically proven urothelial cancer meeting one of the following criteria:
- Stage Ta (WHO grade 2/3, or grade 1 tumors that are either multifocal or > 3 cm
in size)
- Stage T1 (any grade)
- Stage Tis
Exclusion criteria:
- Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within
the 10 years prior to current diagnosis
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Fit for cystoscopy and surgical biopsy/resection
Exclusion criteria:
- HIV infection
- Any 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:
Observational
Study Design:
N/A
Outcome Measure:
Recurrence at 5 years
Principal Investigator
Maurice Zeegers
Investigator Role:
Study Chair
Investigator Affiliation:
University of Birmingham
Authority:
Unspecified
Study ID:
CDR0000574078
NCT ID:
NCT00553566
Start Date:
December 2005
Completion Date:
Related Keywords:
- Bladder Cancer
- stage 0 bladder cancer
- stage I bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
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