<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/NCT03254472</url>
  </required_header>
  <id_info>
    <org_study_id>2017-003438-10</org_study_id>
    <nct_id>NCT03254472</nct_id>
  </id_info>
  <brief_title>Big Data Analysis of the Use of bIomarkers Concentration</brief_title>
  <acronym>rUBIDIuM</acronym>
  <official_title>Defining Use and Misuse of BIoMarkers Dosage and Trends in Observed Concentration Over Time: a BIg Data Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Avicenne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>ProBayes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Biorance Laboratoires Réunis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Avicenne</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 investigators conducted a retrospective analysis of all measured concentrations performed&#xD;
      in a large subset of laboratories located in the French Brittany from February 2010 the 17th&#xD;
      to August 2015 the 30th, in adults over 20 years old.&#xD;
&#xD;
      The investigators are aimed at studying physicians' use and eventually misuse of biomarkers&#xD;
      dosage and the characteristics of a broad population based on some biomarkers concentrations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The rUBIDIuM study is a retrospective analysis that included all tests (but not including DNA&#xD;
      analysis or HIV tests) performed in a large subset of laboratories located in the French&#xD;
      Brittany from February 2010 the 17th to August 2015 the 30th. The area of study covers most&#xD;
      of the Ille-et-Vilaine and a part of the Côtes d'Armor department in Brittany. The respective&#xD;
      surface of these departments is 6775 and 6878 km2. All labs belong to the Biorance Laboratory&#xD;
      group (consortium of 33 labs, Biorance Laboratoires Réunis) and are equipped with Roche&#xD;
      Diagnostics instruments (Elecsys2010® analyzer, Roche diagnostics, Meylan, France).&#xD;
&#xD;
      The main objectives are to study physicians' use and eventually misuse of biomarkers dosage&#xD;
      and the characteristics of this broad population based on some biomarkers concentrations.&#xD;
&#xD;
      For all adult patients &gt;20y that came to a participating lab during the study period, the&#xD;
      investigators collected the following information: demographics data, data about the&#xD;
      prescription (date of order, list of analysis recommended, the date of blood collection and&#xD;
      analysis), about the prescribers and the results of the analyses. After a de-identifying&#xD;
      process, data were aggregated.&#xD;
&#xD;
      the initial analyses will 1) examine the biological tests (number, types…) ordered in a large&#xD;
      cohort of patients, in the total population and the subgroups based on gender, age, time&#xD;
      period, kind of lab and physicians' specialty, 2) examine the results/concentration of the&#xD;
      analyses: blood chemistry, creatinin concentration, cardiac enzymes, natriuretic peptides,&#xD;
      INR, lipid profile, hemogram…&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2010</start_date>
  <completion_date type="Actual">September 10, 2015</completion_date>
  <primary_completion_date type="Actual">August 30, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>biomarker dosage prescription</measure>
    <time_frame>August 2017</time_frame>
    <description>physicians' use and eventually misuse of biomarkers dosage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers dosage numbers</measure>
    <time_frame>August 2017</time_frame>
    <description>Biomarkers dosage numbers before and after new treatments, released of guidelines, new tests...</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers in geriatric patients</measure>
    <time_frame>August 2017</time_frame>
    <description>biomarkers dosages and concentration in elderly/very elderly patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population's characteristics</measure>
    <time_frame>August 2017</time_frame>
    <description>physicians' use and eventually misuse of biomarkers dosage</description>
  </secondary_outcome>
  <enrollment type="Actual">585745</enrollment>
  <condition>Biological Markers</condition>
  <condition>Inappropriate Prescribing</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Measured concentrations of biomarkers</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort that included all analyses performed in a large subset of laboratories located in&#xD;
        the French Brittany from February 2010 the 17th to August 2015 the 30th.&#xD;
&#xD;
        The extract data corresponded to 74,502,510 analyses performed in 585,745 distinct adult&#xD;
        patients &gt;20y&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients &gt;20 that came to a participating lab (Biorance Laboratoires Réunis)&#xD;
             during the study period for biological measurement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DNA analysis, HIV test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christophe Meune, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Avicenne Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Avicenne Hospital</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Avicenne</investigator_affiliation>
    <investigator_full_name>Christophe Meune, MD-PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Biological markers</keyword>
  <keyword>Professional practice</keyword>
  <keyword>Big data analysis</keyword>
  <keyword>Measured concentrations</keyword>
  <keyword>Cardiac markers</keyword>
  <keyword>Troponin</keyword>
  <keyword>NTproBNP</keyword>
  <keyword>Creatinin</keyword>
  <keyword>INR</keyword>
  <keyword>Hemogram</keyword>
  <keyword>Lipid profile</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only aggregated data are available</ipd_description>
  </patient_data>
  <!-- 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/NCT03254472
org study id: 2017-003438-10
nct id: NCT03254472
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators conducted a retrospective analysis of all measured concentrations performed
      in a large subset of laboratories located in the French Brittany from February 2010 the 17th
      to August 2015 the 30th, in adults over 20 years old.

      The investigators are aimed at studying physicians' use and eventually misuse of biomarkers
      dosage and the characteristics of a broad population based on some biomarkers concentrations.
The rUBIDIuM study is a retrospective analysis that included all tests (but not including DNA
      analysis or HIV tests) performed in a large subset of laboratories located in the French
      Brittany from February 2010 the 17th to August 2015 the 30th. The area of study covers most
      of the Ille-et-Vilaine and a part of the Côtes d'Armor department in Brittany. The respective
      surface of these departments is 6775 and 6878 km2. All labs belong to the Biorance Laboratory
      group (consortium of 33 labs, Biorance Laboratoires Réunis) and are equipped with Roche
      Diagnostics instruments (Elecsys2010® analyzer, Roche diagnostics, Meylan, France).

      The main objectives are to study physicians' use and eventually misuse of biomarkers dosage
      and the characteristics of this broad population based on some biomarkers concentrations.

      For all adult patients >20y that came to a participating lab during the study period, the
      investigators collected the following information: demographics data, data about the
      prescription (date of order, list of analysis recommended, the date of blood collection and
      analysis), about the prescribers and the results of the analyses. After a de-identifying
      process, data were aggregated.

      the initial analyses will 1) examine the biological tests (number, types…) ordered in a large
      cohort of patients, in the total population and the subgroups based on gender, age, time
      period, kind of lab and physicians' specialty, 2) examine the results/concentration of the
      analyses: blood chemistry, creatinin concentration, cardiac enzymes, natriuretic peptides,
      INR, lipid profile, hemogram…
observational model: Case-Only
time perspective: Retrospective
measure: biomarker dosage prescription
time frame: August 2017
description: physicians' use and eventually misuse of biomarkers dosage
measure: Biomarkers dosage numbers
time frame: August 2017
description: Biomarkers dosage numbers before and after new treatments, released of guidelines, new tests...
measure: Biomarkers in geriatric patients
time frame: August 2017
description: biomarkers dosages and concentration in elderly/very elderly patients
measure: Population's characteristics
time frame: August 2017
description: physicians' use and eventually misuse of biomarkers dosage
intervention type: Diagnostic Test
intervention name: Measured concentrations of biomarkers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Christophe Meune, MD PhD
role: Principal Investigator
affiliation: Avicenne Hospital
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hospital Avicenne
investigator full name: Christophe Meune, MD-PhD
investigator title: Professor
sharing ipd: No
ipd description: Only aggregated data are available