Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status and phase: Unknown; Phase 3

Conditions: Bladder Cancer

Treatments: Procedure: cytology specimen collection procedure; Procedure: mutation analysis; Procedure: study of socioeconomic and demographic variables; Procedure: quality-of-life assessment; Procedure: chemoprevention; Drug: selenium; Procedure: diagnostic procedure; Procedure: laboratory biomarker analysis; Procedure: polymerase chain reaction; Drug: vitamin E; Procedure: medical chart review; Procedure: questionnaire administration; Procedure: cryopreservation; Procedure: gene expression analysis; Procedure: biopsy; Procedure: immunohistochemistry staining method

Study type: Interventional

Funder types: Other

Identifiers

NCT00553124

EU-20768

CDR0000572089

ISRCTN13889738

CRUK-BCPP-2005-01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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