Trial document




This trial has been registered retrospectively.
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  DRKS00010924

Trial Description

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Title

Biomarker associated with the radiation therapy of renal cell cancer.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

This explorative study examines whether the response of renal cell cancer to stereotactic radiotherapy (SBRT) in 10 patients with von Hippel-Lindau syndrome correlates with modifications in gene expression in peripheral blood and urine. These data can be used to draw conclusions regarding the underlying mechanisms of SBRT (e.g. apoptosis, inflammation, immune response) to optimize dose, application mode and synergistic adjuvant therapies.

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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

  •   DRKS00010924
  •   2016/09/23
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  •   yes
  •   Approved
  •   266/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
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Interventions/Observational Groups

  •   During the course of radiation therapy, expression profiles and proteomic analyses from blood and urine will be used to elucidate the processes induced by radiation.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I
  •   N/A
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Primary Outcome

Modifications of biomarker (urine, blood) in 10 patients

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Secondary Outcome

n/a

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/01/15
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

VHL patients with RCC and SBRT

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Exclusion Criteria

Patients with Hb < 10 g/dL, and patients unable to collect substantial quantities of urine (≥ 250 ml)

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Addresses

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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Anca Ligia  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Strahlenheilkunde
    • Ms.  PD Dr.  Emily  Kim 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Mr.  Dr. med.  Simon  Kirste 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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