NCT00553124

Brief Summary

RATIONALE: Studying different factors that effect patients with newly diagnosed bladder cancer may help doctors learn more about the disease, improve the ability to plan cancer treatment, and help patients live more comfortably. PURPOSE: This clinical trial is studying different factors affecting patients with newly diagnosed bladder cancer.

Trial Health

55
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Trial Health Score

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

Enrollment
3,400

participants targeted

Target at P75+ for phase_3

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

October 1, 2007

First QC Date

November 2, 2007

Last Update Submit

January 9, 2014

Conditions

Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • Recurrence-free interval

  • Progression-free interval

Secondary Outcomes (5)

  • Overall survival time

  • Incidence of transitional cell carcinoma outside the bladder

  • Incidence of all other malignancies clinically diagnosed

  • Incidence of cardiovascular events

  • Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30 questionnaires

Interventions

seleniumDRUG
vitamin EDRUG
biopsyPROCEDURE
chemopreventionPROCEDURE
cryopreservationPROCEDURE
cytology specimen collection procedurePROCEDURE
diagnostic procedurePROCEDURE
gene expression analysisPROCEDURE
immunohistochemistry staining methodPROCEDURE
laboratory biomarker analysisPROCEDURE
medical chart reviewPROCEDURE
mutation analysisPROCEDURE
polymerase chain reactionPROCEDURE
quality-of-life assessmentPROCEDURE
questionnaire administrationPROCEDURE
study of socioeconomic and demographic variablesPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma meeting 1 of the following criteria: * Non-muscle-invasive tumor * Muscle-invasive tumor * Solitary G1 pTa tumor * No 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 * No HIV infection * No 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 discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

SeleniumVitamin EBiopsyChemopreventionCryopreservationGene Expression ProfilingImmunohistochemistryPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMineralsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesDrug TherapyTherapeuticsTissue PreservationHistocytological Preparation TechniquesHistological TechniquesPreservation, BiologicalGenetic TechniquesHistocytochemistryImmunologic TechniquesNucleic Acid Amplification Techniques

Study Officials

  • K. K. Cheng, MD

    University Hospital Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
PREVENTION
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: 2007-10

Locations

GB(1)