Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
selenium
vitamin E
biopsy
chemoprevention
cryopreservation
cytology specimen collection procedure
diagnostic procedure
gene expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
medical chart review
mutation analysis
polymerase chain reaction
quality-of-life assessment
questionnaire administration
study of socioeconomic and demographic variables
Sponsored by
About this trial
This is an interventional prevention trial for Bladder Cancer focused on measuring stage 0 bladder cancer, stage I bladder cancer, stage II bladder cancer, transitional cell carcinoma of the bladder
Eligibility Criteria
DISEASE CHARACTERISTICS:
Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma meeting 1 of the following criteria:
- Non-muscle-invasive tumor
- Muscle-invasive tumor
- Solitary G1 pTa tumor
- No previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis
PATIENT CHARACTERISTICS:
- Fit for cystoscopy and surgical biopsy/resection
- No HIV infection
- No 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
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS TrustRecruiting
Outcomes
Primary Outcome Measures
Recurrence-free interval
Progression-free interval
Secondary Outcome Measures
Overall survival time
Incidence of transitional cell carcinoma outside the bladder
Incidence of all other malignancies clinically diagnosed
Incidence of cardiovascular events
Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires
Full Information
NCT ID
NCT00553124
First Posted
November 2, 2007
Last Updated
January 9, 2014
Sponsor
University Hospital Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00553124
Brief Title
Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer
Official Title
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
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 Hospital Birmingham
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Studying different factors that effect patients with newly diagnosed bladder cancer may help doctors learn more about the disease, improve the ability to plan cancer treatment, and help patients live more comfortably.
PURPOSE: This clinical trial is studying different factors affecting patients with newly diagnosed bladder cancer.
Detailed Description
OBJECTIVES:
To assess the effect of lifestyle factors (e.g., smoking, dietary habits, fluid intake, or environmental exposures) on the recurrence and progression of bladder cancer.
To assess the impact of selenium and/or vitamin E on the progression and recurrence of bladder cancer.
To study health-related quality of life and its association with recurrence and progression of bladder cancer.
To establish a bladder cancer tissue bank that will comprise blood, urine, and bladder tissue.
To study the predictive effect of molecular markers on the recurrence and progression of bladder cancer.
OUTLINE: This is a multicenter study.
The study will be based on a cohort of patients with newly detected bladder cancer in all 16 urological centres within the West Midlands, commencing in late 2005 for a period of 5 years. This research project consists of 5 individual studies: CRUK-BCPP-2005-01-COHORT, CRUK-BCPP-2005-01-MARKERS, CRUK-BCPP-2005-01-QOL, CRUK-BCPP-2005-01-TISSUE-BANK, and CRUK-BCPP-2005-01-TREATMENT. Patients may participate in all or only some of these individual studies.
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, stage II bladder cancer, transitional cell carcinoma of the bladder
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Enrollment
3400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
selenium
Intervention Type
Drug
Intervention Name(s)
vitamin E
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
chemoprevention
Intervention Type
Procedure
Intervention Name(s)
cryopreservation
Intervention Type
Procedure
Intervention Name(s)
cytology specimen collection procedure
Intervention Type
Procedure
Intervention Name(s)
diagnostic procedure
Intervention Type
Procedure
Intervention Name(s)
gene expression analysis
Intervention Type
Procedure
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Procedure
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
medical chart review
Intervention Type
Procedure
Intervention Name(s)
mutation analysis
Intervention Type
Procedure
Intervention Name(s)
polymerase chain reaction
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
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-free interval
Title
Progression-free interval
Secondary Outcome Measure Information:
Title
Overall survival time
Title
Incidence of transitional cell carcinoma outside the bladder
Title
Incidence of all other malignancies clinically diagnosed
Title
Incidence of cardiovascular events
Title
Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma meeting 1 of the following criteria:
Non-muscle-invasive tumor
Muscle-invasive tumor
Solitary G1 pTa tumor
No previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis
PATIENT CHARACTERISTICS:
Fit for cystoscopy and surgical biopsy/resection
No HIV infection
No 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
K. K. Cheng, MD
Organizational Affiliation
University Hospital Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. K. Cheng, MD
Phone
44-121-414-6757
12. IPD Sharing Statement
Learn more about this trial
Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer
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