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
Recruitment status was Recruiting
Sponsor:
University Hospital Birmingham
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00553124
First received: November 2, 2007
Last updated: November 9, 2007
Last verified: October 2007
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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:
Genetics Home Reference related topics:
bladder cancer
Drug Information available for:
alpha-Tocopherol
Tocopherol
Selenomethionine
Vitamin E succinate
Tocopherol acetate
dl-alpha-Tocopherol
U.S. FDA Resources
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 |
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: | November 9, 2007 |
| 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 May 23, 2013