Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: selenium
* Drug: vitamin E
* Procedure: biopsy
* Procedure: chemoprevention
* Procedure: cryopreservation
* Procedure: cytology specimen collection procedure
* Procedure: diagnostic procedure
* Procedure: gene expression analysis
* Procedure: immunohistochemistry staining method
* Procedure: laboratory biomarker analysis
* Procedure: medical chart review
* Procedure: mutation analysis
* Procedure: polymerase chain reaction
* Procedure: quality-of-life assessment
* Procedure: questionnaire administration
* Procedure: study of socioeconomic and demographic variables


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: selenium|nan|
|Drug: vitamin E|nan|
|Procedure: biopsy|nan|
|Procedure: chemoprevention|nan|
|Procedure: cryopreservation|nan|
|Procedure: cytology specimen collection procedure|nan|
|Procedure: diagnostic procedure|nan|
|Procedure: gene expression analysis|nan|
|Procedure: immunohistochemistry staining method|nan|
|Procedure: laboratory biomarker analysis|nan|
|Procedure: medical chart review|nan|
|Procedure: mutation analysis|nan|
|Procedure: polymerase chain reaction|nan|
|Procedure: quality-of-life assessment|nan|
|Procedure: questionnaire administration|nan|
|Procedure: study of socioeconomic and demographic variables|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free interval |  |  | 
| Progression-free interval |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time |  |  | 
| Incidence of transitional cell carcinoma outside the bladder |  |  | 
| Incidence of all other malignancies clinically diagnosed |  |  | 
| Incidence of cardiovascular events |  |  | 
| Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage 0 bladder cancer, stage I bladder cancer, stage II bladder cancer, transitional cell carcinoma of the bladder