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Trial Title:
Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer
NCT ID:
NCT00553124
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Vitamin E
Selenium
Conditions: Keywords:
stage 0 bladder cancer
stage I bladder cancer
stage II bladder cancer
transitional cell carcinoma of the bladder
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Primary purpose:
Prevention
Intervention:
Intervention type:
Drug
Intervention name:
selenium
Intervention type:
Drug
Intervention name:
vitamin E
Intervention type:
Procedure
Intervention name:
biopsy
Intervention type:
Procedure
Intervention name:
chemoprevention
Intervention type:
Procedure
Intervention name:
cryopreservation
Intervention type:
Procedure
Intervention name:
cytology specimen collection procedure
Intervention type:
Procedure
Intervention name:
diagnostic procedure
Intervention type:
Procedure
Intervention name:
gene expression analysis
Intervention type:
Procedure
Intervention name:
immunohistochemistry staining method
Intervention type:
Procedure
Intervention name:
laboratory biomarker analysis
Intervention type:
Procedure
Intervention name:
medical chart review
Intervention type:
Procedure
Intervention name:
mutation analysis
Intervention type:
Procedure
Intervention name:
polymerase chain reaction
Intervention type:
Procedure
Intervention name:
quality-of-life assessment
Intervention type:
Procedure
Intervention name:
questionnaire administration
Intervention type:
Procedure
Intervention name:
study of socioeconomic and demographic variables
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Address:
City:
Birmingham
Zip:
B15 2TH
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
K. K. Cheng, MD
Phone:
44-121-414-6757
Start date:
December 2005
Lead sponsor:
Agency:
University Hospital Birmingham
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00553124
