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

NCT ID: NCT00553566

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-12-31

Brief Summary

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.

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.

Conditions

Bladder Cancer

Interventions

medical chart review

Intervention Type: PROCEDURE

questionnaire administration

Intervention Type: PROCEDURE

study of socioeconomic and demographic variables

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Fit for cystoscopy and surgical biopsy/resection

Exclusion Criteria

• Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis

PATIENT CHARACTERISTICS:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Birmingham

OTHER

Sponsor Role: lead

Principal Investigators

Maurice Zeegers

Role: STUDY_CHAIR

University of Birmingham

Locations

University of Birmingham

Edgbaston, England, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Maurice Zeegers

Role: primary

44-121-414-6721

Other Identifiers

CRUK-BCPP-2005-01-COHORT

Identifier Type: -

Identifier Source: secondary_id

ISRCTN13889738

Identifier Type: -

Identifier Source: secondary_id

EU-20768

Identifier Type: -

Identifier Source: secondary_id

CDR0000574078

Identifier Type: -

Identifier Source: org_study_id