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| ID | Type | Description | Link |
|---|---|---|---|
| CRUK-BCPP-2005-01 | |||
| ISRCTN13889738 | |||
| EU-20768 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selenium | Drug | |||
| vitamin E | Drug | |||
| biopsy | Procedure | |||
| chemoprevention | Procedure | |||
| cryopreservation | Procedure | |||
| cytology specimen collection procedure | Procedure | |||
| diagnostic procedure | Procedure | |||
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free interval | ||
| Progression-free interval |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival time | ||
| Incidence of transitional cell carcinoma outside the bladder | ||
| Incidence of all other malignancies clinically diagnosed |
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DISEASE CHARACTERISTICS:
Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma meeting 1 of the following criteria:
No previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| K. K. Cheng, MD | University Hospital Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Recruiting | Birmingham | England | B15 2TH | United Kingdom |
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| 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 | Procedure |
| Incidence of cardiovascular events |
| Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D012643 | Selenium |
| D014810 | Vitamin E |
| D001706 | Biopsy |
| D018890 | Chemoprevention |
| D015925 | Cryopreservation |
| D020869 | Gene Expression Profiling |
| D007150 | Immunohistochemistry |
| D016133 | Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D014021 | Tissue Preservation |
| D016591 | Histocytological Preparation Techniques |
| D006652 | Histological Techniques |
| D011309 | Preservation, Biological |
| D005821 | Genetic Techniques |
| D006651 | Histocytochemistry |
| D007158 | Immunologic Techniques |
| D021141 | Nucleic Acid Amplification Techniques |
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