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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00553566
Enrollment
1600
Registered
2007-11-05
Start date
2005-12-31
Completion date
Unknown
Last updated
2014-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder

Brief 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.

Interventions

PROCEDUREmedical chart review
PROCEDUREquestionnaire administration
PROCEDUREstudy of socioeconomic and demographic variables

Sponsors

University of Birmingham
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Recurrence at 5 years
Progression at 5 years

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026