CClinicalTrials.gg
Status unknownNCT00553566Updated Jan 10, 2014

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

An observational study in Bladder Cancer, sponsored by University of Birmingham. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-10.

Sponsored by University of Birmingham · Observational

The sponsor has not verified this record recently (last verified Feb 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Enrollment
1,600
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bladder Cancer

Keywords

  • stage 0 bladder cancer
  • stage I bladder cancer
  • transitional cell carcinoma of the bladder
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 1,600 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

University of Birmingham is the lead sponsor of 179 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Enrollment
1,600 participants

Interventions

  • Proceduremedical chart review
  • Procedurequestionnaire administration
  • Procedurestudy of socioeconomic and demographic variables
06

What researchers measure

Primary outcomes

  1. Recurrence at 5 years

  2. Progression at 5 years

07

Study locations

1 of 1 sites recruiting
  • University of Birmingham
    Edgbaston, England B15 2TT, United Kingdom
    • Maurice Zeegers · Contact · 44-121-414-6721
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00553566
Lead sponsor
University of Birmingham
First posted
Nov 4, 2007
Start date
Dec 2005
Last update
Jan 10, 2014

Study contacts

Maurice Zeegers
study chair · University of Birmingham
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion