Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

NCT ID: NCT00553124

Last Updated: 2014-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

3400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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selenium

Intervention Type DRUG

vitamin E

Intervention Type DRUG

biopsy

Intervention Type PROCEDURE

chemoprevention

Intervention Type PROCEDURE

cryopreservation

Intervention Type PROCEDURE

cytology specimen collection procedure

Intervention Type PROCEDURE

diagnostic procedure

Intervention Type PROCEDURE

gene expression analysis

Intervention Type PROCEDURE

immunohistochemistry staining method

Intervention Type PROCEDURE

laboratory biomarker analysis

Intervention Type PROCEDURE

medical chart review

Intervention Type PROCEDURE

mutation analysis

Intervention Type PROCEDURE

polymerase chain reaction

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

questionnaire administration

Intervention Type PROCEDURE

study of socioeconomic and demographic variables

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Birmingham

OTHER

Sponsor Role lead

Principal Investigators

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K. K. Cheng, MD

Role: STUDY_CHAIR

University Hospital Birmingham

Locations

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Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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K. K. Cheng, MD

Role: primary

44-121-414-6757

Other Identifiers

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CRUK-BCPP-2005-01

Identifier Type: -

Identifier Source: secondary_id

ISRCTN13889738

Identifier Type: -

Identifier Source: secondary_id

EU-20768

Identifier Type: -

Identifier Source: secondary_id

CDR0000572089

Identifier Type: -

Identifier Source: org_study_id

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