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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
