Trial document




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  DRKS00003592

Trial Description

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Title

Urinary LASP-1 as diagnostic marker for detection of transitional cell carcinoma of the urinary bladder

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The detection of the protein LASP-1 in the urine is associated with a 85% sensitivity and specificty for the presence of bladder cancer. After promising initial results (Ardelt et al, Urol Oncol, 2012, in press) this study will further evaluate the diagnostic use. Eligible are patients with the suspicion of bladder cancer who undergo a cystoscopic evaluation.

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Brief Summary in Scientific Language

Urinary LASP-1 has recently been shown to be predictive for presence of a transitional cell carcinoma of the bladder due to enhanced cell shedding through and an increased expression of LASP-1. This study will further analyse the diagnostic value and perform a multivariate analysis of confounding factors. Eligible are all patients with suspicion of bladder cancer.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003592
  •   2012/03/08
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  •   yes
  •   Approved
  •   79/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C67 -  Malignant neoplasm of bladder
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Interventions/Observational Groups

  •   Patiens with Bladder tumor. The urinary LASP-1 content ist measured.
  •   Healthy donors, patients without tumor(verified by cystoscopy and/or biopsy. The urinary LASP-1 content is measured.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Measurement of urinary LASP-1 content. Korrelation to cystoscopical and/or histological result. Multivariate analysis of sensitivity, specificity, positive and negative predictive value. Confounding factors, such as tumor size, grading, staging will be included

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/01
  •   1000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   1   Years
  •   99   Years
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Additional Inclusion Criteria

Any patient with suspected bladder cancer

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Exclusion Criteria

None

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Addresses

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    • Chirurgische Universtitätsklinik, Abteilung Urologie Universitätsklinik Freiburg
    • Mr.  Dr  Peter  Ardelt 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Chirurgische Universitätsklinik, Abteilung für Urologie
    • Mr.  Dr  Peter  Ardelt 
    • Hugstetter Strasse 55
    • 79106  Freiubrg
    • Germany
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    • Chirurgische Universitätsklinik, Abteilung für Urologie
    • Mr.  Dr  Fabian  Adams 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Chirurgische Universitätsklinik, Abteilung für Urologie
    • Mr.  Dr  Peter  Ardelt 
    • Hugstetter Strasse 55
    • 79106  Freiubrg
    • Germany
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    • Stiftung für Pathobiochemie und Molekulare Diagnostik
    • Maximiliansstrasse 6
    • 76133  Karlsruhe
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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