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

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. 

Official Title

Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial).

Conditions

• Bladder Cancer

Study Type

Observational

Study Design

Further Details

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.

Study Start

December 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and older
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

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:

• Solitary grade 1 pTa tumors
• Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis.

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

Pior Concurrant Therapy:

• Not specified

Total Enrolment

1600

Contact Details

KK Cheng, MD     
University Hospital Birmingham

Location:

Queen Elizabeth Hospital
University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH