Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 3,400
- 试验地点
- 2
- 主要终点
- Recurrence-free interval
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Recurrence-free interval
Progression-free interval
次要结局
- 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