xml: <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/NCT06040008</url>
    </required_header>
    <id_info>
      <org_study_id>IS 01-2023</org_study_id>
      <nct_id>NCT06040008</nct_id>
    </id_info>
    <brief_title>Investigating the Impact of Environmental Factors on the Transcriptomics Profile in Healthy Individuals</brief_title>
    <acronym>IMEN</acronym>
    <official_title>Investigating the Impact of Environmental Factors on the Transcriptomics Profile in Healthy Individuals: Comparison of PaxGene RNA Tube and Dried-Blood-Spot Filter Card (CENTOCARD®)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CENTOGENE GmbH Rostock</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CENTOGENE GmbH Rostock</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Changes in biology will be reflected by changes in the composition of Ribonucleic acid (RNA)&#xD;
        in the blood. An example of that would be environmental changes, e.g. diet, acute illness,&#xD;
        temperature. The main goal of this study is to study the impact of environmental changes in&#xD;
        blood transcriptomics in healthy individuals over time.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The project is aiming to evaluate the impact of environmental changes on the blood&#xD;
        transcriptome and to assess the feasibility of different sample collection materials for this&#xD;
        purpose. Transcriptome from EDTA-DBS. Performing RNAseq from EDTA-DBS, Finger-Prick- DBS and&#xD;
        PAXgene RNA tubes has resulted in different levels of analytical &quot;background noise&quot;.&#xD;
  &#xD;
        To measure the reflection of this noise, we aim to collect and evaluate blood samples of&#xD;
        participating healthy individuals on different time points, to discover how suitable, the DBS&#xD;
        is in detecting changes caused by environmental factors (diet, acute disease, temperature).&#xD;
        The environmental factors should have variable severity of changes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 9, 2023</start_date>
    <completion_date type="Anticipated">April 8, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 8, 2024</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>study the impact of environmental changes in blood transcriptomics</measure>
      <time_frame>12 months</time_frame>
      <description>Changes in biology will be reflected by changes in the composition of Ribonucleic acid (RNA) in the blood. An example of that would be environmental changes, e.g. diet, acute illness, temperature.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>different sample collection materials</measure>
      <time_frame>12 months</time_frame>
      <description>The secondary goal is to evaluate the feasibility of different sample collection materials. RNA collected from PAXgene RNA tubes is a gold standard for RNA extraction from blood.&#xD;
  However, CENTOGENE devised an alternative method to obtain RNA from CentoCard® (or Dried-Blood-Spot card/DBS). There is a systematic difference between these methods regarding the extraction and depletion of hemoglobin.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>healthy volunteers</arm_group_label>
      <description>Healthy status is defined by the absence of evidence of any active or chronic disease at the beginning of the study</description>
    </arm_group>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>blood collection</intervention_name>
      <description>3 blood collections over a period of 6 weeks&#xD;
  V0 - Inclusion&#xD;
  V1 - 3 weeks ± 14 days&#xD;
  V2 - 3 weeks ± 14 days&#xD;
  1 EDTA 4 ml tube, 1 PAXgene RNA tube 2,5 ml and drops of blood from finger-prick are taken at each visit&#xD;
  Clinical information obtained at each visit</description>
      <arm_group_label>healthy volunteers</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          healthy participants&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Voluntary, informed consent is obtained from the subject before enrollment in the&#xD;
               study&#xD;
  &#xD;
            -  The subject is 18 years or older (≥18 years)&#xD;
  &#xD;
            -  Healthy participants, as declared by the subject&#xD;
  &#xD;
            -  Healthy status is defined by the absence of evidence of any active or chronic disease&#xD;
               at the beginning of the study&#xD;
  &#xD;
            -  Available to participate for the planned duration of the study for which the screening&#xD;
               is being done&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • The subject had any clinically significant disease&#xD;
  &#xD;
                 -  Any clinically relevant history or the presence of e.g., respiratory, renal,&#xD;
                    hepatic, gastrointestinal, hematological, lymphatic, neurological,&#xD;
                    cardiovascular, psychiatric, etc. chronic disease&#xD;
  &#xD;
                 -  Concomitant disease or condition that could interfere with, or treatment of which&#xD;
                    might interfere with, the conduct of the study, or that would, in the opinion of&#xD;
                    the investigator, pose an unacceptable risk to the subject in this study&#xD;
  &#xD;
                 -  A condition in which repeated blood draws poses more than minimal risk for the&#xD;
                    subject such as hemophilia, other severe coagulation disorders or significantly&#xD;
                    impaired venous access&#xD;
  &#xD;
                 -  In the opinion of the investigator, subject is at high risk of non-compliance and&#xD;
                    is unsuitable in any other way to participate in this study&#xD;
  &#xD;
                 -  No informed consent obtained from the subject&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Tobias Böttcher, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CENTOGENE GmbH Rostock</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Studies</last_name>
      <phone>+49 381 80113-400</phone>
      <email>imenstudy@centogene.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centogene GmbH</name>
        <address>
          <city>Rostock</city>
          <state>MV</state>
          <zip>18055</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Studies</last_name>
        <phone>+49 381 80113-400</phone>
        <email>imenstudy@centogene.com</email>
      </contact>
      <investigator>
        <last_name>Tobias Böttcher, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Healthy volunteers</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040008
  org study id: IS 01-2023
  nct id: NCT06040008
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Changes in biology will be reflected by changes in the composition of Ribonucleic acid (RNA)
        in the blood. An example of that would be environmental changes, e.g. diet, acute illness,
        temperature. The main goal of this study is to study the impact of environmental changes in
        blood transcriptomics in healthy individuals over time.
  The project is aiming to evaluate the impact of environmental changes on the blood
        transcriptome and to assess the feasibility of different sample collection materials for this
        purpose. Transcriptome from EDTA-DBS. Performing RNAseq from EDTA-DBS, Finger-Prick- DBS and
        PAXgene RNA tubes has resulted in different levels of analytical "background noise".
  
        To measure the reflection of this noise, we aim to collect and evaluate blood samples of
        participating healthy individuals on different time points, to discover how suitable, the DBS
        is in detecting changes caused by environmental factors (diet, acute disease, temperature).
        The environmental factors should have variable severity of changes.
  observational model: Cohort
  time perspective: Prospective
  measure: study the impact of environmental changes in blood transcriptomics
  time frame: 12 months
  description: Changes in biology will be reflected by changes in the composition of Ribonucleic acid (RNA) in the blood. An example of that would be environmental changes, e.g. diet, acute illness, temperature.
  measure: different sample collection materials
  time frame: 12 months
  description: The secondary goal is to evaluate the feasibility of different sample collection materials. RNA collected from PAXgene RNA tubes is a gold standard for RNA extraction from blood.
  However, CENTOGENE devised an alternative method to obtain RNA from CentoCard® (or Dried-Blood-Spot card/DBS). There is a systematic difference between these methods regarding the extraction and depletion of hemoglobin.
  arm group label: healthy volunteers
  description: Healthy status is defined by the absence of evidence of any active or chronic disease at the beginning of the study
  intervention type: Genetic
  intervention name: blood collection
  description: 3 blood collections over a period of 6 weeks
  V0 - Inclusion
  V1 - 3 weeks ± 14 days
  V2 - 3 weeks ± 14 days
  1 EDTA 4 ml tube, 1 PAXgene RNA tube 2,5 ml and drops of blood from finger-prick are taken at each visit
  Clinical information obtained at each visit
  arm group label: healthy volunteers
  Blood
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Tobias Böttcher, MD
  role: Principal Investigator
  affiliation: CENTOGENE GmbH Rostock
  last name: Clinical Studies
  phone: +49 381 80113-400
  email: imenstudy@centogene.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Germany
  responsible party type: Sponsor
  sharing ipd: No