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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)

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.

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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 3400 participants
Primary Purpose: Prevention
Official Title: Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)
Study Start Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Primary Outcome Measures :
  1. Recurrence-free interval
  2. Progression-free interval

Secondary Outcome Measures :
  1. Overall survival time
  2. Incidence of transitional cell carcinoma outside the bladder
  3. Incidence of all other malignancies clinically diagnosed
  4. Incidence of cardiovascular events
  5. Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00553124

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United Kingdom
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      
Sponsors and Collaborators
University Hospital Birmingham
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Study Chair: K. K. Cheng, MD University Hospital Birmingham

Layout table for additonal information Identifier: NCT00553124     History of Changes
Other Study ID Numbers: CDR0000572089
First Posted: November 5, 2007    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: October 2007
Keywords provided by National Cancer Institute (NCI):
stage 0 bladder cancer
stage I bladder cancer
stage II bladder cancer
transitional cell carcinoma of the bladder
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements