Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

Sponsor

University Hospital Birmingham (Other)

Overall Status

Unknown status

CT.gov ID

NCT00553124

Collaborator

(none)

3,400

Enrollment

Location

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Prevention

Official Title:

Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)

Study Start Date :

Dec 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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