Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00553124
First received: November 2, 2007
Last updated: January 9, 2014
Last verified: October 2007

November 2, 2007
January 9, 2014
December 2005
Not Provided
  • Recurrence-free interval
  • Progression-free interval
Same as current
Complete list of historical versions of study NCT00553124 on ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.

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.

Interventional
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3400
Not Provided
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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
Both
18 Years and older
No
Not Provided
United Kingdom
 
NCT00553124
CDR0000572089, CRUK-BCPP-2005-01, ISRCTN13889738, EU-20768
Not Provided
Not Provided
University Hospital Birmingham
Not Provided
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