NCT00553124

Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,400 (planned)
• Sponsor: University Hospital Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	selenium
DRUG	vitamin E
PROCEDURE	biopsy
PROCEDURE	chemoprevention
PROCEDURE	cryopreservation
PROCEDURE	cytology specimen collection procedure
PROCEDURE	diagnostic procedure
PROCEDURE	gene expression analysis
PROCEDURE	immunohistochemistry staining method
PROCEDURE	laboratory biomarker analysis
PROCEDURE	medical chart review
PROCEDURE	mutation analysis
PROCEDURE	polymerase chain reaction
PROCEDURE	quality-of-life assessment
PROCEDURE	questionnaire administration
PROCEDURE	study of socioeconomic and demographic variables

Timeline

• Start date: 2005-12-01
• First posted: 2007-11-05
• Last updated: 2014-01-10

Locations

1 site across 1 country: United Kingdom