Trial document




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  DRKS00013039

Trial Description

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Title

Polymodal Reconnaissance in Urothelial Cancer Deploying Epigenetic Network and Transcriptome Analyses

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Trial Acronym

PRUDENT

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URL of the Trial

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Brief Summary in Lay Language

Patients with neoplasia of the urinary bladder receive operative treatment either endoscopically or via open surgery. After completion of the respective routine diagnostics, the study will conduct further molecular investigations to better understand and treat bladder cancer. In endoscopically treated patients, a further small sample of healthy bladder tissue will be resected. This ensures that comparisons cannot only be made between patients, but also within different tissues of the same patients.

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Brief Summary in Scientific Language

Molecular and histological characterisation of urothelial cancer and intraindividual correlation to healthy tissue.

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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

  •   DRKS00013039
  •   2018/03/15
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  •   yes
  •   Approved
  •   498/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1202-1773 
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Health Condition or Problem studied

  •   C67 -  Malignant neoplasm of bladder
  •   C66 -  Malignant neoplasm of ureter
  •   C65 -  Malignant neoplasm of renal pelvis
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Interventions/Observational Groups

  •   Analysis of tissue/blood/urine after completion of routine diagnostics.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Molecular and histological characterization.

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Secondary Outcome

Correlation to clinical data. Prediction regarding response to therapy, progress, recurrence.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/03/28
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   110   Years
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Additional Inclusion Criteria

Indication to transurethral or open resection of urothelial cancer. Consent provided.

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Exclusion Criteria

Consent not provided. Consent cannot be given by the patient themselve.

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Addresses

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    • Klinik für Urologie Universitätsklinikum Freiburg i. Br.
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgDepartment ChirurgieKlilnik für Urologie
    • Mr.  Dr. med.  Simon  Hein 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgDepartment ChirurgieKlilnik für Urologie
    • Mr.  Dr. med.  Simon  Hein 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Urologie Universitätsklinikum Freiburg i. Br.
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Deutsches Konsortium Translationale Krebsforschung Standort Freiburg, Deutsches Krebsforschungszentrum
    • Im Neuenheimer Feld 280
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting suspended on temporary hold
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Trial Publications, Results and other Documents

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