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Clinical Trials/NCT00553124
NCT00553124
Unknown
Phase 3

Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)

University Hospital Birmingham1 site in 1 country3,400 target enrollmentDecember 2005

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Bladder Cancer
Sponsor
University Hospital Birmingham
Enrollment
3400
Locations
1
Primary Endpoint
Recurrence-free interval
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
University Hospital Birmingham

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Recurrence-free interval

Progression-free interval

Secondary Outcomes

  • 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

Study Sites (1)

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