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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recurrence-free interval
  • Progression-free interval

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 3400
Study Start Date: December 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553124

Locations
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
Investigators
Study Chair: K. K. Cheng, MD University Hospital Birmingham
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00553124     History of Changes
Other Study ID Numbers: CDR0000572089, CRUK-BCPP-2005-01, ISRCTN13889738, EU-20768
Study First Received: November 2, 2007
Last Updated: January 9, 2014
Health Authority: Unspecified

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:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Selenium
Vitamin E
Vitamins
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on April 21, 2014