Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer
Conditions
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
Study Phase
Phase 3
Study Design
N/A
Intervention
Name: medical chart review Type: Procedure
Name: questionnaire administration Type: Procedure
Name: study of socioeconomic and demographic variables Type: Procedure
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
University of Birmingham
Edgbaston, England, United Kingdom
Status: Recruiting
Contact: Maurice Zeegers - 44-121-414-6721
Start Date
December 2005
Sponsors
University of Birmingham
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page