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Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2007

Sponsored by: University Hospital Birmingham
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00553566
  Purpose

RATIONALE: Learning about the long-term effects of dietary, lifestyle, and environmental factors on the risk of cancer progression and recurrence may help the study of bladder cancer in the future.

PURPOSE: This clinical trial is studying how dietary, lifestyle, and environmental factors affect patients with early-stage bladder cancer.


Condition Intervention Phase
Bladder Cancer
Procedure: medical chart review
Procedure: questionnaire administration
Procedure: study of socioeconomic and demographic variables
Phase III

Genetics Home Reference related topics:   bladder cancer   

MedlinePlus related topics:   Bladder Cancer    Cancer   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [COHORT]

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recurrence at 5 years
  • Progression at 5 years

Estimated Enrollment:   1600
Study Start Date:   December 2005

Detailed Description:

OBJECTIVES:

  • To examine if common and potentially modifiable dietary, lifestyle, and environmental exposures affect the risk of recurrence and progression in bladder cancer.

OUTLINE: This is a multicenter study.

Detailed information will be collected about the patients' lifestyle and their exposure to risk factors associated with bladder cancer using semi-structured questionnaires. A baseline questionnaire will be administered at the time of diagnosis and will collect information about socio-demographics, environmental exposures, medical history, diet, health-related quality of life, and social support.

Further questionnaires will be administered at regular follow-up visits to capture information relating to changes in exposure. A postal questionnaire will be used to collect historical information that may require the patient to check records or consult family or friends. Patients will also be asked to keep a 1-week food, fluid, and micturition diary.

Patients continue to complete questionnaires at 3 months and then annually for up to 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Enrolled on parent protocol CRUK-BCPP-2005-01
  • Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma
  • Histologically proven urothelial cancer meeting one of the following criteria:

    • Stage Ta (WHO grade 2/3, or grade 1 tumors that are either multifocal or > 3 cm in size)
    • Stage T1 (any grade)
    • Stage Tis

Exclusion criteria:

  • Solitary grade 1 pTa tumors
  • Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Fit for cystoscopy and surgical biopsy/resection

Exclusion criteria:

  • HIV infection
  • Any 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553566

Locations
United Kingdom, England
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust     Recruiting
      Birmingham, England, United Kingdom, B15 2TH
      Contact: K. K. Cheng, MD     44-121-414-6757        

Sponsors and Collaborators
University Hospital Birmingham

Investigators
Study Chair:     K. K. Cheng, MD     University Hospital Birmingham    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000574078, CRUK-BCPP-2005-01-COHORT, ISRCTN13889738, EU-20768
First Received:   November 2, 2007
Last Updated:   November 2, 2007
ClinicalTrials.gov Identifier:   NCT00553566
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage 0 bladder cancer  
stage I bladder cancer  
transitional cell carcinoma of the bladder  

Study placed in the following topic categories:
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Transitional cell carcinoma
Urinary tract neoplasm
Bladder neoplasm
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 07, 2008




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