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Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

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Status
Sponzori
University Hospital Birmingham

Ključne riječi

Sažetak

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.

Opis

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.

Datumi

Posljednja provjera: 09/30/2007
Prvo podneseno: 11/01/2007
Predviđena prijava poslana: 11/01/2007
Prvo objavljeno: 11/03/2007
Posljednje ažuriranje poslano: 01/08/2014
Posljednje ažuriranje objavljeno: 01/09/2014
Stvarni datum početka studija: 11/30/2005

Stanje ili bolest

Bladder Cancer

Intervencija / liječenje

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

Faza

Faza 3

Kriterij prihvatljivosti

Dobni uvjeti za studiranje 18 Years Do 18 Years
Spolovi koji ispunjavaju uvjete za studijAll
Prihvaća zdrave volontereDa
Kriteriji

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

Ishod

Primarne mjere ishoda

1. Recurrence-free interval [undefined]

2. Progression-free interval [undefined]

Sekundarne mjere ishoda

1. Overall survival time [undefined]

2. Incidence of transitional cell carcinoma outside the bladder [undefined]

3. Incidence of all other malignancies clinically diagnosed [undefined]

4. Incidence of cardiovascular events [undefined]

5. Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires [undefined]

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