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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00553566
• Other study ID #: CDR0000574078
• Secondary ID: CRUK-BCPP-2005-0
• Status: Recruiting
• Phase: Phase 3
• First received: November 2, 2007
• Last updated: January 9, 2014
• Start date: December 2005

Study information

• Verified date: February 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• medical chart review

• questionnaire administration

• study of socioeconomic and demographic variables

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Edgbaston	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence at 5 years
Primary	Progression at 5 years