NCT00553566

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
Last Updated

January 10, 2014

Status Verified

February 1, 2010

First QC Date

November 2, 2007

Last Update Submit

January 9, 2014

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancerstage I bladder cancertransitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (2)

  • Recurrence at 5 years

  • Progression at 5 years

Interventions

medical chart reviewPROCEDURE
questionnaire administrationPROCEDURE
study of socioeconomic and demographic variablesPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis
  • PATIENT CHARACTERISTICS:
  • Fit for cystoscopy and surgical biopsy/resection
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham

Edgbaston, England, B15 2TT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Maurice Zeegers

    University of Birmingham

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 5, 2007

Study Start

December 1, 2005

Last Updated

January 10, 2014

Record last verified: 2010-02

Locations

GB(1)