Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer

Study Overview
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Brief Summary
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RATIONALE: Learning about the long-term effects of dietary, lifestyle, and environmental factors on the risk of cancer progression and recurrence may help the study of bladder cancer in the future. PURPOSE: This clinical trial is studying how dietary, lifestyle, and environmental factors affect patients with early-stage bladder cancer.

Detailed Description
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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.

Official Title
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Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [COHORT]

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: medical chart review
* Procedure: questionnaire administration
* Procedure: study of socioeconomic and demographic variables


Participation Criteria
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Eligibility Criteria
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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

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: medical chart review|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 at 5 years |  |  | 
| Progression at 5 years |  |  | 

 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, transitional cell carcinoma of the bladder