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

January 9, 2014 updated by: University of Birmingham

Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [COHORT]

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Edgbaston, England, United Kingdom, B15 2TT
        • Recruiting
        • University of Birmingham
        • Contact:
          • Maurice Zeegers
          • Phone Number: 44-121-414-6721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Recurrence at 5 years
Progression at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Investigators

  • Study Chair: Maurice Zeegers, University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000574078
  • ISRCTN13889738
  • EU-20768
  • CRUK-BCPP-2005-01-COHORT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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