Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
medical chart review
questionnaire administration
study of socioeconomic and demographic variables
Sponsored by
About this trial
This is an observational trial for Bladder Cancer focused on measuring stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
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
Sites / Locations
- University of BirminghamRecruiting
Outcomes
Primary Outcome Measures
Recurrence at 5 years
Progression at 5 years
Secondary Outcome Measures
Full Information
NCT ID
NCT00553566
First Posted
November 2, 2007
Last Updated
January 9, 2014
Sponsor
University of Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00553566
Brief Title
Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer
Official Title
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [COHORT]
Study Type
Observational
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Birmingham
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
7. Study Design
Enrollment
1600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
medical chart review
Intervention Type
Procedure
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
study of socioeconomic and demographic variables
Primary Outcome Measure Information:
Title
Recurrence at 5 years
Title
Progression at 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Zeegers
Organizational Affiliation
University of Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Birmingham
City
Edgbaston
State/Province
England
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurice Zeegers
Phone
44-121-414-6721
12. IPD Sharing Statement
Learn more about this trial
Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer
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