Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer
NCT ID: NCT00553124
Last Updated: 2014-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
3400 participants
INTERVENTIONAL
2005-12-31
Brief Summary
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PURPOSE: This clinical trial is studying different factors affecting patients with newly diagnosed bladder cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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PREVENTION
Interventions
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selenium
vitamin E
biopsy
chemoprevention
cryopreservation
cytology specimen collection procedure
diagnostic procedure
gene expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
medical chart review
mutation analysis
polymerase chain reaction
quality-of-life assessment
questionnaire administration
study of socioeconomic and demographic variables
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital Birmingham
OTHER
Principal Investigators
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K. K. Cheng, MD
Role: STUDY_CHAIR
University Hospital Birmingham
Locations
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Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Countries
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Facility Contacts
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K. K. Cheng, MD
Role: primary
Other Identifiers
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CRUK-BCPP-2005-01
Identifier Type: -
Identifier Source: secondary_id
ISRCTN13889738
Identifier Type: -
Identifier Source: secondary_id
EU-20768
Identifier Type: -
Identifier Source: secondary_id
CDR0000572089
Identifier Type: -
Identifier Source: org_study_id
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