Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004155

Trial Description

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Title

An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study PCB305/04, to Assess Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Transurethral Resection of the Bladder (TURB) or White Light Cystoscopy/TURB

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study is intended to investigate whether the improved initial detection and resection of
bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix
(Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences
compared to standard white light cystoscopy/TURB.

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Brief Summary in Scientific Language

A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence
rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white
light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who
underwent white light cystoscopy and TURB alone.

The present study is intended to investigate whether the improved initial detection and
resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with
Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in
recurrences compared to standard white light cystoscopy/TURB.

No safety data was collected.

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Organizational Data

  •   DRKS00004155
  •   2012/09/19
  •   2010/07/19
  •   no
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Secondary IDs

  •   NCT01166230  (ClinicalTrials.gov)
  •   PC B305/E10  (PhotoCure)
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Health Condition or Problem studied

  •   Bladder Cancer
  •   C67 -  Malignant neoplasm of bladder
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Recurrence Free Survival; time frame: up to 4.5 years

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Secondary Outcome

- Rate of Progression; time frame: 4.5 years; Only patients with Ta/T1 were included in the follow-up study. "Progression" is defined as presence of T2-T4 tumors, with or without carcinoma in situ (CIS), at worst recurrence.

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Countries of Recruitment

  •   United States
  •   Austria
  •   Canada
  •   Germany
  •   Netherlands
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Locations of Recruitment

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Recruitment

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  •   2010/06/30
  •   521
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients of study PC B305/04 with Ta or T1, that were followed for recurrence are
eligible to be included in this study.

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Exclusion Criteria

- Patient died during clinical study PC B305/04

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Addresses

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    • Photocure
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    • The University of Texas, MD Anderson Cancer Center
    • Herbert Barton Grossman, MD 
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    • The University of Texas, MD Anderson Cancer Center
    • Herbert Barton Grossman, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2010/12/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.