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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00553566
First received: November 2, 2007
Last updated: February 15, 2010
Last verified: February 2010
History of Changes
  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 3

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

Resource links provided by NLM:

U.S. FDA Resources

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:

  • 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
University of Birmingham Recruiting
Edgbaston, England, United Kingdom, B15 2TT
Contact: Maurice Zeegers     44-121-414-6721        
Sponsors and Collaborators
University of Birmingham
Investigators
Study Chair: Maurice Zeegers University of Birmingham
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00553566     History of Changes
Other Study ID Numbers: CDR0000574078, CRUK-BCPP-2005-01-COHORT, ISRCTN13889738, EU-20768
Study First Received: November 2, 2007
Last Updated: February 15, 2010
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013