Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00553124
• Other study ID #: CDR0000572089
• Secondary ID: CRUK-BCPP-2005-0
• Status: Recruiting
• Phase: Phase 3
• First received: November 2, 2007
• Last updated: January 9, 2014
• Start date: December 2005

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• selenium

• vitamin E

Procedure:
• biopsy

• chemoprevention

• cryopreservation

• cytology specimen collection procedure

• diagnostic procedure

• gene expression analysis

• immunohistochemistry staining method

• laboratory biomarker analysis

• medical chart review

• mutation analysis

• polymerase chain reaction

• quality-of-life assessment

• questionnaire administration

• study of socioeconomic and demographic variables

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust	Birmingham	England

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free interval
Primary	Progression-free interval
Secondary	Overall survival time
Secondary	Incidence of transitional cell carcinoma outside the bladder
Secondary	Incidence of all other malignancies clinically diagnosed
Secondary	Incidence of cardiovascular events
Secondary	Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires