Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

November 2, 2007
November 5, 2007
January 10, 2014
December 2005
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  • Recurrence-free interval
  • Progression-free interval
Same as current
Complete list of historical versions of study NCT00553124 on Archive Site
  • 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
Same as current
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Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)

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.


  • 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.

Phase 3
Primary Purpose: Prevention
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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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  • 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


  • 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


  • Not specified
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
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University Hospital Birmingham
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Study Chair: K. K. Cheng, MD University Hospital Birmingham
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP