Trial document




drksid header

  DRKS00008308

Trial Description

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Title

Collection of cerebrospinal fluid and performing skin biopsies for obtaining fibroblasts for studies at the DZNE

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Trial Acronym

Collection of Biosamples

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URL of the Trial

[---]*

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Brief Summary in Lay Language

If already participating in other studies (eg DESCRIBE) of the DZNE and due to the course of the observed disease, it could turn out to be useful with respect to scientific questions that subjects provide additional cerebrospinal fluid and / or connective tissue of the skin.
Furthermore, non-affected healthy controls and / or relatives are willing to provide cerebrospinal fluid and / or connective tissue for scientific purposes. The removed tissue cells can be reprogrammed into neurons, where metabolic pathways can then be analyzed directly.

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Brief Summary in Scientific Language

If already participating in other studies (eg DESCRIBE) of the DZNE and due to the course of the observed disease, it could turn out to be useful with respect to scientific questions that subjects provide additional cerebrospinal fluid and / or fibroblasts of the skin.
Furthermore, non-affected healthy controls and / or relatives are willing to provide cerebrospinal fluid and / or fibroblasts for scientific purposes. The removed fibroblasts can be trans-differentiated into neurons, where metabolic pathways can then be analyzed directly.

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Organizational Data

  •   DRKS00008308
  •   2015/09/16
  •   [---]*
  •   yes
  •   Approved
  •   313/14, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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

  •   G30.0 -  Alzheimer disease with early onset
  •   G30.1 -  Alzheimer disease with late onset
  •   G30.8 -  Other Alzheimer disease
  •   G30.9 -  Alzheimer disease, unspecified
  •   G20 -  Parkinson disease
  •   G21 -  Secondary parkinsonism
  •   G22 -  Parkinsonism in diseases classified elsewhere
  •   G31.82 -  [generalization G31.8: Other specified degenerative diseases of nervous system]
  •   G23.1 -  Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski]
  •   G11.1 -  Early-onset cerebellar ataxia
  •   G11.0 -  Congenital nonprogressive ataxia
  •   G11.2 -  Late-onset cerebellar ataxia
  •   G11.3 -  Cerebellar ataxia with defective DNA repair
  •   G11.4 -  Hereditary spastic paraplegia
  •   G11.8 -  Other hereditary ataxias
  •   G11.9 -  Hereditary ataxia, unspecified
  •   G12.2 -  Motor neuron disease
  •   G12.0 -  Infantile spinal muscular atrophy, type I [Werdnig-Hoffman]
  •   G12.1 -  Other inherited spinal muscular atrophy
  •   I68.0 -  Cerebral amyloid angiopathy
  •   Neurodegenerative healthy subjects (healthy controls)
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Interventions/Observational Groups

  •   Collection of cerebrospinal fluid for studies at the DZNE
  •   Performing skin biopsies for obtaining fibroblasts in studies of DZNE
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Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Collection of cerebrospinal fluid and performing skin biopsies for obtaining fibroblasts for studies at the DZNE

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/08/31
  •   [---]*
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Existing participation in a clinical trial of the DZNE - Written informed consent to participate in a lumbar puncture and / or skin biopsy

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Exclusion Criteria

- failure of capacity to consent
- clinically unstable or serious diseases
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contraindications regarding lumbar puncture.: • inflammation of the skin, subcutaneous tissue and / or muscles in the puncture area • suspicion of increased intracranial pressure • existence of a cerebral lesion • intolerance to latex, local anesthetics, disinfectants, adhesive plaster • intake of anticoagulants • known disorder of blood clotting • immunosuppression
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contraindications regarding skin biopsy.: • intolerance to latex, local anesthetics, disinfectants, adhesive plaster • intake of anticoagulants • known disorder of blood clotting • immunosuppression • known tendency to keloid formation

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Addresses

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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE)
    • Sigmund-Freud-Str. 27
    • 53127  Bonn
    • Germany
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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE)c/o Klinik für Neurologie
    • Mr.  Prof. Dr. med.  Thomas  Klockgether 
    • Sigmund-Freud-Str. 25
    • 53105  Bonn
    • Germany
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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE)
    • Ms.  Verena  Pross 
    • Sigmund-Freud-Str. 27
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE)
    • Sigmund-Freud-Str. 27
    • 53127  Bonn
    • 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.