<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/NCT02208206</url>
  </required_header>
  <id_info>
    <org_study_id>NeuroPain CBF_01</org_study_id>
    <nct_id>NCT02208206</nct_id>
  </id_info>
  <brief_title>Analysis of Markers in the Blood Correlated With Neuropathic Pain</brief_title>
  <official_title>Neuropathic Pain: Association Between Phenotype and Biomarkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christoph Stein, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>deCODE genetics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyze associations between symptoms and specific markers in&#xD;
      the blood in patients suffering from neuropathic pain linked to diseases of different origin.&#xD;
      Such markers could be utilized in the future for precise diagnosis of neuropathic pain and&#xD;
      might lead to targeted pain treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On average, 3-8% of the German population suffers from neuropathic pain, which can occur&#xD;
      after damage of somatosensory nerves in the peripheral or central nervous system. In terms of&#xD;
      a &quot;personalized&quot; medicine, only a strict separation of neuropathic and chronic pain allows an&#xD;
      individualized therapy to reduce pain severity and to enhance patients' quality of life.&#xD;
&#xD;
      Currently, the diagnosis of neuropathic pain is based on the medical history, the subjective&#xD;
      description of somatosensory symptoms and the application of (non-genetic) diagnostic tests.&#xD;
      To improve diagnosis and therapy of complex disorders for individual patients, novel methods&#xD;
      are introduced based on flow cytometric (FACS) analysis of human immune cells or analysis of&#xD;
      the human genome (genomics). Those techniques can support the identification of&#xD;
      characteristic features indicating ongoing individual pathophysiologic processes in the body&#xD;
      (biomarkers).&#xD;
&#xD;
      Often diseases are based on a complex relationship between genetics, environmental factors&#xD;
      and the manifestation of the disease. To capture this complexity via genomics, phenotypical&#xD;
      and genotypical data of high quality and detailed information about the study population are&#xD;
      required.&#xD;
&#xD;
      This observational study includes patients suffering from painful and non-painful&#xD;
      neuropathies associated with HIV-infection, diabetes mellitus and breast cancer. With the&#xD;
      targeted application of validated questionnaires (such as the Brief Pain Inventory, Pain&#xD;
      Catastrophizing Scale, Hospital Anxiety and Depression Scale, Ten-Item Personality Inventory,&#xD;
      36-Item Short Form Health Survey, and the Insomnia Severity Index) and parallel usage of&#xD;
      genomics or FACS analysis of selected biomarkers in the blood, this study will provide&#xD;
      information about the manifestation of certain genes or immune markers which are directly&#xD;
      correlated to the symptoms of the disease. Additional performance of&#xD;
      neuropsychological/cognitive tests and quantitative sensory testing (QST) will enhance the&#xD;
      phenotypic profile. Identification of potential indicators could be utilized prospectively to&#xD;
      precisely diagnose and effectively treat neuropathic pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of gene expression</measure>
    <time_frame>Assessment - 1 day</time_frame>
    <description>Investigation of associations between phenotypic and genotypic data. Patients with chronic painful and non-painful neuropathy will be phenotyped in detail using validated questionnaires related to pain (Brief Pain Inventory and Numeric Rating Scale), mental health (Pain Catastrophizing Scale and Hospital Anxiety and Depression Rating Scale), personality (Ten-Item Personality Inventory) and quality of life (36-Item Short Form Health Survey and Insomnia Severity Index). Optional, a set of neuropsychological/cognitive tests and quantitative sensory testing (QST) will be performed. DNA will be isolated from patients' blood samples and analyzed for genetic variants which might have an effect on the development of neuropathic pain. Once, phenotypic and genotypic data are available they will be associated with each other with the goal to find genetic variants tied to pain phenotypes and which might serve as novel DNA biomarkers for neuropathic pain.</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Neuropathy</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, plasma, serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitals, primary care clinics, resident physicians&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-associated neuropathy&#xD;
&#xD;
          -  Sufficient knowledge of the German language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-incident severe central nervous system diseases&#xD;
&#xD;
          -  Major psychiatric conditions&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Limited mental capacity or limited German language skills&#xD;
&#xD;
          -  Intoxication with alcohol or recreational drugs within the last 48 hours of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph Stein, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology Charite</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Operative Intensive Care Medicine, Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Christoph Stein, MD</investigator_full_name>
    <investigator_title>Clinical director</investigator_title>
  </responsible_party>
  <keyword>Neuropathic pain</keyword>
  <keyword>Phenotype</keyword>
  <keyword>Genotype</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>HIV</keyword>
  <keyword>Diabetes mellitus</keyword>
  <keyword>Breast cancer</keyword>
  <keyword>Genomics</keyword>
  <keyword>Quantitative sensory testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</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/NCT02208206
org study id: NeuroPain CBF_01
nct id: NCT02208206
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to analyze associations between symptoms and specific markers in
      the blood in patients suffering from neuropathic pain linked to diseases of different origin.
      Such markers could be utilized in the future for precise diagnosis of neuropathic pain and
      might lead to targeted pain treatment.
On average, 3-8% of the German population suffers from neuropathic pain, which can occur
      after damage of somatosensory nerves in the peripheral or central nervous system. In terms of
      a "personalized" medicine, only a strict separation of neuropathic and chronic pain allows an
      individualized therapy to reduce pain severity and to enhance patients' quality of life.

      Currently, the diagnosis of neuropathic pain is based on the medical history, the subjective
      description of somatosensory symptoms and the application of (non-genetic) diagnostic tests.
      To improve diagnosis and therapy of complex disorders for individual patients, novel methods
      are introduced based on flow cytometric (FACS) analysis of human immune cells or analysis of
      the human genome (genomics). Those techniques can support the identification of
      characteristic features indicating ongoing individual pathophysiologic processes in the body
      (biomarkers).

      Often diseases are based on a complex relationship between genetics, environmental factors
      and the manifestation of the disease. To capture this complexity via genomics, phenotypical
      and genotypical data of high quality and detailed information about the study population are
      required.

      This observational study includes patients suffering from painful and non-painful
      neuropathies associated with HIV-infection, diabetes mellitus and breast cancer. With the
      targeted application of validated questionnaires (such as the Brief Pain Inventory, Pain
      Catastrophizing Scale, Hospital Anxiety and Depression Scale, Ten-Item Personality Inventory,
      36-Item Short Form Health Survey, and the Insomnia Severity Index) and parallel usage of
      genomics or FACS analysis of selected biomarkers in the blood, this study will provide
      information about the manifestation of certain genes or immune markers which are directly
      correlated to the symptoms of the disease. Additional performance of
      neuropsychological/cognitive tests and quantitative sensory testing (QST) will enhance the
      phenotypic profile. Identification of potential indicators could be utilized prospectively to
      precisely diagnose and effectively treat neuropathic pain.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Analysis of gene expression
time frame: Assessment - 1 day
description: Investigation of associations between phenotypic and genotypic data. Patients with chronic painful and non-painful neuropathy will be phenotyped in detail using validated questionnaires related to pain (Brief Pain Inventory and Numeric Rating Scale), mental health (Pain Catastrophizing Scale and Hospital Anxiety and Depression Rating Scale), personality (Ten-Item Personality Inventory) and quality of life (36-Item Short Form Health Survey and Insomnia Severity Index). Optional, a set of neuropsychological/cognitive tests and quantitative sensory testing (QST) will be performed. DNA will be isolated from patients' blood samples and analyzed for genetic variants which might have an effect on the development of neuropathic pain. Once, phenotypic and genotypic data are available they will be associated with each other with the goal to find genetic variants tied to pain phenotypes and which might serve as novel DNA biomarkers for neuropathic pain.
Whole blood, plasma, serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christoph Stein, Prof.
role: Principal Investigator
affiliation: Department of Anesthesiology Charite
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Christoph Stein, MD
investigator title: Clinical director
mesh term: Neuralgia