Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer - Full Text View

Sponsored by:	University Hospital Birmingham
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00553124

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 III

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Selenium

U.S. FDA Resources

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

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, England
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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000572089, CRUK-BCPP-2005-01, ISRCTN13889738, EU-20768
Study First Received:	November 2, 2007
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00553124
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

Study placed in the following topic categories:

Tocopherol acetate
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Transitional cell carcinoma

Carcinoma
Alpha-Tocopherol
Tocopherols
Selenium
Vitamin E
Urologic Diseases
Urinary tract neoplasm
Bladder neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009