Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

University Hospital Birmingham3,400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

PREVENTION

Enrollment

3,400

Conditions

Bladder Cancer

Interventions

seleniumDRUG

vitamin EDRUG

biopsyPROCEDURE

chemopreventionPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, United Kingdom

RECRUITING

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

Data from ClinicalTrials.gov

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