<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/NCT04501315</url>
  </required_header>
  <id_info>
    <org_study_id>S100B ICU</org_study_id>
    <nct_id>NCT04501315</nct_id>
  </id_info>
  <brief_title>S100B in Intensive Care Patients With and Without Traumatic Brain Injury</brief_title>
  <official_title>S100B in Intensive Care Patients With and Without Traumatic Brain Injury: Implications for Neuromarker Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The neurotrophic protein S100B has been promoted as a neuromarker for decades, and to reflect&#xD;
      the severity of brain injury. On the other hand, S100B is a tumor marker. The interpretation&#xD;
      of its serum levels may be altered by a contribution from extracerebral sources and its renal&#xD;
      elimination.&#xD;
&#xD;
      In the present study we investigate the relevance of S100B as a prognostic factor, as well as&#xD;
      the correlation with different CT classifications in a large cohort of patients with and&#xD;
      without brain injury. Furthermore, we examine whether S100B is elevated in brain tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg, undergoing&#xD;
      surgery for sellar lesions were prospectively included. The study protocol was approved by&#xD;
      the local Ethical Committee. Informed written consent was given by the participants or the&#xD;
      next-of-kin in each case. Exclusion criteria comprised of those below 18 years of age,&#xD;
      pregnancy and a drug intolerance.&#xD;
&#xD;
      Patients baseline information included age, gender, clinical presentation, and preexisting&#xD;
      medical conditions. In four different cohorts of patients, S100B was measured:&#xD;
&#xD;
        1. ICU TBI, patients treated on the ICU with brain injury&#xD;
&#xD;
        2. ICU tumor, patients treated on the ICU because of an intracranial tumor&#xD;
&#xD;
        3. ICU surgery, patients treated on the ICU following surgery without brain injury&#xD;
&#xD;
        4. ICU control, patients treated on the ICU without TBI, tumor or surgery&#xD;
&#xD;
      The performed diagnostic tests included blood, cerebrospinal fluid and urine samples. In all&#xD;
      subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected&#xD;
      daily as part of the clinical routine at 6:00 AM.&#xD;
&#xD;
      Samples were immediately centrifuged for 10min at 1.300xG and 4°C and stored at a temperature&#xD;
      of -80°C until the assays were performed. Analysis was performed with commercially available&#xD;
      kits on automated immunoanalyzers (LIAISON® Sangtec®100 by chemiluminescence immunoassay,&#xD;
      Diasorin). The sensitivity of the assay was 0.02ng/ml.&#xD;
&#xD;
      In all cohorts the clinical status was documented with Glasgow Coma Score (GCS), and the&#xD;
      outcome was assessed applying the Glasgow Outcome Score (GOS) or the Karnofsky Status Scale.&#xD;
      The radiological work-up included a computed tomography (CT) or a magnetic resonance imaging&#xD;
      (MRI). In brain injured patients, the CT was classifiied by the Marshall and Rotterdam Score.&#xD;
      Extracranial injuries or surgical procedures were documented&#xD;
&#xD;
      Statistical analysis was performed with SPSS, and p&lt;0.05 was accepted as significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2007</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Glascow Outcome Score (GOS)</measure>
    <time_frame>up to one year post admission</time_frame>
    <description>The Glascow Outcome Scale classifies patients by objective degree of recovery, Minimum 1: death - Maximum 5: good recovery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Karnofsky Performance Status Score</measure>
    <time_frame>up to one year post admission</time_frame>
    <description>Karnofsky Performance Status Scale describes patients functional status as a comprehensive 11 point scale correlatig to percentage values ranging from 100% ( no evidence of disease, no symptoms) to 0% ( death)</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">600</enrollment>
  <condition>Tumor</condition>
  <condition>Brain Injuries</condition>
  <condition>Trauma Injury</condition>
  <condition>Critical Illness</condition>
  <condition>Surgery--Complications</condition>
  <arm_group>
    <arm_group_label>ICU TBI</arm_group_label>
    <description>Patients treated on the ICU with brain injury</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICU tumor</arm_group_label>
    <description>Patients treated on the ICU because of intracranial tumor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICU surgery</arm_group_label>
    <description>Patients treated on the ICU following surgery without brain injury</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICU control</arm_group_label>
    <description>Patients treated on the ICU without TBI, tumor or surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood, cerebrospinal fluid and urine samples</intervention_name>
    <description>In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.</description>
    <arm_group_label>ICU TBI</arm_group_label>
    <arm_group_label>ICU control</arm_group_label>
    <arm_group_label>ICU surgery</arm_group_label>
    <arm_group_label>ICU tumor</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, cerebrospinal fluid, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg,&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients of the Department of Neurosurgery, University of Erlangen Nürnberg, patients&#xD;
             with traumatic brain injury,&#xD;
&#xD;
          -  patients with intracranial tumor,&#xD;
&#xD;
          -  intensive care patients,&#xD;
&#xD;
          -  informed written consent was given by the Patient or the next of kin in each case.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg Medical School</investigator_affiliation>
    <investigator_full_name>Andrea Kleindienst, MD, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>S100B</keyword>
  <keyword>biomarker</keyword>
  <keyword>CT-classification</keyword>
  <keyword>outcome</keyword>
  <keyword>histology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT04501315
org study id: S100B ICU
nct id: NCT04501315
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The neurotrophic protein S100B has been promoted as a neuromarker for decades, and to reflect
      the severity of brain injury. On the other hand, S100B is a tumor marker. The interpretation
      of its serum levels may be altered by a contribution from extracerebral sources and its renal
      elimination.

      In the present study we investigate the relevance of S100B as a prognostic factor, as well as
      the correlation with different CT classifications in a large cohort of patients with and
      without brain injury. Furthermore, we examine whether S100B is elevated in brain tumors.
Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg, undergoing
      surgery for sellar lesions were prospectively included. The study protocol was approved by
      the local Ethical Committee. Informed written consent was given by the participants or the
      next-of-kin in each case. Exclusion criteria comprised of those below 18 years of age,
      pregnancy and a drug intolerance.

      Patients baseline information included age, gender, clinical presentation, and preexisting
      medical conditions. In four different cohorts of patients, S100B was measured:

        1. ICU TBI, patients treated on the ICU with brain injury

        2. ICU tumor, patients treated on the ICU because of an intracranial tumor

        3. ICU surgery, patients treated on the ICU following surgery without brain injury

        4. ICU control, patients treated on the ICU without TBI, tumor or surgery

      The performed diagnostic tests included blood, cerebrospinal fluid and urine samples. In all
      subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected
      daily as part of the clinical routine at 6:00 AM.

      Samples were immediately centrifuged for 10min at 1.300xG and 4°C and stored at a temperature
      of -80°C until the assays were performed. Analysis was performed with commercially available
      kits on automated immunoanalyzers (LIAISON® Sangtec®100 by chemiluminescence immunoassay,
      Diasorin). The sensitivity of the assay was 0.02ng/ml.

      In all cohorts the clinical status was documented with Glasgow Coma Score (GCS), and the
      outcome was assessed applying the Glasgow Outcome Score (GOS) or the Karnofsky Status Scale.
      The radiological work-up included a computed tomography (CT) or a magnetic resonance imaging
      (MRI). In brain injured patients, the CT was classifiied by the Marshall and Rotterdam Score.
      Extracranial injuries or surgical procedures were documented

      Statistical analysis was performed with SPSS, and p<0.05 was accepted as significant.
observational model: Cohort
time perspective: Prospective
measure: Glascow Outcome Score (GOS)
time frame: up to one year post admission
description: The Glascow Outcome Scale classifies patients by objective degree of recovery, Minimum 1: death - Maximum 5: good recovery
measure: Karnofsky Performance Status Score
time frame: up to one year post admission
description: Karnofsky Performance Status Scale describes patients functional status as a comprehensive 11 point scale correlatig to percentage values ranging from 100% ( no evidence of disease, no symptoms) to 0% ( death)
arm group label: ICU TBI
description: Patients treated on the ICU with brain injury
arm group label: ICU tumor
description: Patients treated on the ICU because of intracranial tumor
arm group label: ICU surgery
description: Patients treated on the ICU following surgery without brain injury
arm group label: ICU control
description: Patients treated on the ICU without TBI, tumor or surgery
intervention type: Diagnostic Test
intervention name: Blood, cerebrospinal fluid and urine samples
description: In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.
arm group label: ICU TBI
arm group label: ICU control
arm group label: ICU surgery
arm group label: ICU tumor
Serum, cerebrospinal fluid, urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg Medical School
investigator full name: Andrea Kleindienst, MD, PhD
investigator title: Associate Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Critical Illness
mesh term: Wounds and Injuries