Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer
|ClinicalTrials.gov Identifier: NCT00553124|
Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : November 5, 2007
Last Update Posted : January 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||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||Phase 3|
- 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 (Clinical Trial)|
|Estimated Enrollment :||3400 participants|
|Official Title:||Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)|
|Study Start Date :||December 2005|
- Recurrence-free interval
- Progression-free interval
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553124
|Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust||Recruiting|
|Birmingham, England, United Kingdom, B15 2TH|
|Contact: K. K. Cheng, MD 44-121-414-6757|
|Study Chair:||K. K. Cheng, MD||University Hospital Birmingham|