<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02222779</url>
  </required_header>
  <id_info>
    <org_study_id>KPUK-14-Metal</org_study_id>
    <nct_id>NCT02222779</nct_id>
  </id_info>
  <brief_title>Quantification of Transition Metals</brief_title>
  <official_title>Quantification of Transition Metals in Patients at the Cologne University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cologne</source>
  <brief_summary>
    <textblock>
      In this trial, concentrations of transition metals of interest are quantified in surplus&#xD;
      cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals&#xD;
      will be performed by inductively coupled plasma mass spectrometry (ICP-MS). The treating&#xD;
      physicians as well as the patients will not be informed about the results of drug&#xD;
      concentrations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Samples used include:&#xD;
&#xD;
      Remaining portions of samples collected for diagnostic or therapeutic reasons (paired CSF and&#xD;
      blood serum samples). No lumbar puncture will be done specifically for this protocol.&#xD;
&#xD;
      The objective of this study is to gain an overview about transition metals concentrations in&#xD;
      blood serum and CSF in order to provide preliminary data on patients. The effect of&#xD;
      neurodegenerative diseases on metals or the other way round will be assessed if possible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Transition metal concentration</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Neurodegenerative Diseases</condition>
  <condition>Infections</condition>
  <arm_group>
    <arm_group_label>Patients with Parkinson´s Disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient´s with Alzheimer´s Disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with Multiple Sclerosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with any other neurodegenerative diseases</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Remaining portions of samples collected for diagnostic or therapeutic reasons (paired CSF and&#xD;
      blood serum samples). No lumbar puncture will be done specifically for this protocol.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        neurodegenerative diseases infections&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: •&#xD;
&#xD;
          -  The trial will include any patient (with various diseases, especially&#xD;
             neurodegenerative diseases) who received a lumbar puncture.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • The lower age limit is 18 years. In concordance with the objective of the project&#xD;
             there is no specific exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Uwe Fuhr, Professor</last_name>
    <phone>0049221478</phone>
    <phone_ext>5230</phone_ext>
    <email>uwe.fuhr@uk-koeln.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Pharmacology</name>
      <address>
        <city>Cologne</city>
        <state>Northrhine Westphalia</state>
        <zip>50829</zip>
        <country>Germany</country>
      </address>
    </facility>
    <contact>
      <last_name>Uwe Fuhr, Professor</last_name>
      <phone>0049221478</phone>
      <phone_ext>5230</phone_ext>
      <email>uwe.fuhr@uk-koeln.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cologne</investigator_affiliation>
    <investigator_full_name>Ali Mohammad Nejad Sigaroudi</investigator_full_name>
    <investigator_title>Quantification of Transition Metals in Patients at the Cologne University Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurodegenerative Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02222779
org study id: KPUK-14-Metal
nct id: NCT02222779
lead sponsor: 
In this trial, concentrations of transition metals of interest are quantified in surplus
      cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals
      will be performed by inductively coupled plasma mass spectrometry (ICP-MS). The treating
      physicians as well as the patients will not be informed about the results of drug
      concentrations.
Samples used include:

      Remaining portions of samples collected for diagnostic or therapeutic reasons (paired CSF and
      blood serum samples). No lumbar puncture will be done specifically for this protocol.

      The objective of this study is to gain an overview about transition metals concentrations in
      blood serum and CSF in order to provide preliminary data on patients. The effect of
      neurodegenerative diseases on metals or the other way round will be assessed if possible.
observational model: Ecologic or Community
measure: Transition metal concentration
time frame: 5 years
arm group label: Patients with Parkinson´s Disease
arm group label: Patient´s with Alzheimer´s Disease
arm group label: Patients with Multiple Sclerosis
arm group label: Patients with any other neurodegenerative diseases
Remaining portions of samples collected for diagnostic or therapeutic reasons (paired CSF and
      blood serum samples). No lumbar puncture will be done specifically for this protocol.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Uwe Fuhr, Professor
phone: 0049221478
phone ext: 5230
email: uwe.fuhr@uk-koeln.de
facility: 
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Cologne
investigator full name: Ali Mohammad Nejad Sigaroudi
investigator title: Quantification of Transition Metals in Patients at the Cologne University Hospital
mesh term: Neurodegenerative Diseases