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

NCT ID: NCT00553566

Condition: Bladder Cancer

Conditions: Official terms:
Urinary Bladder Neoplasms

Conditions: Keywords:
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder

Study type: Observational

Overall status: Unknown status

Intervention:

Intervention type: Procedure
Intervention name: medical chart review

Intervention type: Procedure
Intervention name: questionnaire administration

Intervention type: Procedure
Intervention name: study of socioeconomic and demographic variables

Summary: 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: 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.

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Birmingham

Address:
City: Edgbaston
Zip: B15 2TT
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Maurice Zeegers

Phone: 44-121-414-6721

Start date: December 2005

Lead sponsor:
Agency: University of 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/NCT00553566

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