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

University of Birmingham

Status: Unknown

Conditions: Bladder Cancer

Treatments: Procedure: medical chart review; Procedure: study of socioeconomic and demographic variables; Procedure: questionnaire administration

Study type: Observational

Funder types: Other

Identifiers

NCT00553566

CRUK-BCPP-2005-01-COHORT

EU-20768

ISRCTN13889738

CDR0000574078

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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