Trial document




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  DRKS00019808

Trial Description

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Title

Pre-, peri- and post-operative complications in patients with brain metastases

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Trial Acronym

ASCOBRA: Assessment of Complications in Patients with Brain Metastases

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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

The aim of this retrospective study is the exploration of mutual risk factors that influence disease progression and outcome of surgically treated patients with intracerebral metastases. We analyze patient data, histological / molecular data, treatment strategies, early / late complications and patient outcome. The inclusion of this data set into currently used treatment algorithms is highly warranted.

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Organizational Data

  •   DRKS00019808
  •   2019/11/11
  •   [---]*
  •   yes
  •   Approved
  •   18-8475-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C79.3 -  Secondary malignant neoplasm of brain and cerebral meninges
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Interventions/Observational Groups

  •   Patients that receive surgical treatment for intracerebral metastases are included and risk factors for disease progression and treatment complications are evaluated.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of demographical, clinical, radiological, histological and molecular data in the context of disease progression and treatment complications. Treatment allocation and follow-up data is used for this study. Neuropathological analyses on the tumor specimen are necessary to receive histological and molecular data. Statistical analyses comprise univariate and multivariate analyses.

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Secondary Outcome

Effectivity and eligibility of routinely applied treatment algorithms are analyzed in order to improve the treatment of future patients.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/12/01
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

(1) Radiographic detection of intracerebral metastases of extracranial origin.
(2) Surgical treatment in the recruiting department.

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Exclusion Criteria

[---]*

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Addresses

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    • Universitätsklinikum Essen, Klinik für Neurochirurgie und Wirbelsäulenchirurgie
    • Mr.  Laurèl  Rauschenbach 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen, Klinik für Neurochirurgie und Wirbelsäulenchirurgie
    • Mr.  PD Dr. med.  Ramazan  Jabbarli 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen, Klinik für Neurochirurgie und Wirbelsäulenchirurgie
    • Mr.  Laurèl  Rauschenbach 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen, Klinik für Neurochirurgie und Wirbelsäulenchirurgie
    • Mr.  Laurèl  Rauschenbach 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen, Klinik für Neurochirurgie und Wirbelsäulenchirurgie
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    •   0049-201-723-1201
    •   0049-201-723-1220
    •   [---]*
    •   [---]*
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Status

  •   Recruiting planned
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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.