Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
stage 0 bladder cancer, stage I bladder cancer, stage II bladder cancer, transitional cell carcinoma of the bladder
Study Type
Study Phase
Phase 3
Study Design
Primary Purpose: Prevention
Name: selenium Type: Drug
Name: vitamin E Type: Drug
Name: biopsy Type: Procedure
Name: chemoprevention Type: Procedure
Name: cryopreservation Type: Procedure
Name: cytology specimen collection procedure Type: Procedure
Name: diagnostic procedure Type: Procedure
Name: gene expression analysis Type: Procedure
Name: immunohistochemistry staining method Type: Procedure
Name: laboratory biomarker analysis Type: Procedure
Name: medical chart review Type: Procedure
Name: mutation analysis Type: Procedure
Name: polymerase chain reaction Type: Procedure
Name: quality-of-life assessment Type: Procedure
Name: questionnaire administration Type: Procedure
Name: study of socioeconomic and demographic variables Type: Procedure
Overall Status
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

- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both

- 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


- 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


- Not specified
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Status: Recruiting
Contact: K. K. Cheng, MD - 44-121-414-6757
Start Date
December 2005
University Hospital Birmingham
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page