<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/NCT03299855</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A01079-44</org_study_id>
    <nct_id>NCT03299855</nct_id>
  </id_info>
  <brief_title>MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?</brief_title>
  <acronym>MOCA-2</acronym>
  <official_title>MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Francois Baclesse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UCOG (Unite de coordination en Onco-Gériatrie)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Francois Baclesse</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>
      This study concerns elderly patients with cancer with onco-geriatric assessment.&#xD;
&#xD;
      This study propose to associate the collection of the results with the Mini-Cog and the CODEX&#xD;
      with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment,&#xD;
      in order to determine if the patients have cognitive impairments, to evaluate the sensitivity&#xD;
      of these 4 screening tests in elderly patients seeking treatment for their cancer. The&#xD;
      results of this study will make it possible, where appropriate, to adapt the practice in the&#xD;
      context of oncogeriatric assessment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 13, 2017</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Passation of MMS and MoCA tests associated to passation of neuropsychological test</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the sensitivity of MoCA test</measure>
    <time_frame>Up 2 months after inclusion, before initiation of treatment</time_frame>
    <description>MoCA is considered clinically relevant if its sensitivity to identify patients with cognitive impairment is at least 75%</description>
  </primary_outcome>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Neoplasms</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Passation of neuropsychological test</intervention_name>
    <description>Passation of MoCA and MMS tests associated with neuropsychological test</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged over 70 years&#xD;
&#xD;
          -  Patient with cancer (solid tumor or haemopathy) for whom a first line treatment is&#xD;
             envisaged (whatever it is). Surgery and radiotherapy are allowed before entry into the&#xD;
             study.&#xD;
&#xD;
          -  Patient candidate for oncogeriatric assessment&#xD;
&#xD;
          -  Patient agree to participate in the study&#xD;
&#xD;
          -  Using the French language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary central nervous system or cerebral metastasis&#xD;
&#xD;
          -  Evolutionary psychiatric pathology known (e.g. schizophrenia)&#xD;
&#xD;
          -  Severe Visual and / or Auditory Impairment&#xD;
&#xD;
          -  Patients unable to respond to cognitive tests&#xD;
&#xD;
          -  Patient (s) deprived of liberty, under guardianship or curatorship&#xD;
&#xD;
          -  Refusal of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>florence JOLY, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre François Baclesse</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Florence JOLY, Prof</last_name>
    <phone>0231455050</phone>
    <email>f.joly@baclesse.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie LANGE</last_name>
    <email>m.lange@baclesse.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marianne HAMON, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bérengère BEAUPLET, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH</name>
      <address>
        <city>Cherbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laure KALUZINSKI, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch Compiegne</name>
      <address>
        <city>Compiègne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurence DELTOUR, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Olivier RIGAL, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier</name>
      <address>
        <city>Saint-Lô</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Isabelle CRINIERE, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oncogeriatric</keyword>
  <keyword>MMS</keyword>
  <keyword>MoCA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Cognition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03299855
org study id: 2017-A01079-44
nct id: NCT03299855
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study concerns elderly patients with cancer with onco-geriatric assessment.

      This study propose to associate the collection of the results with the Mini-Cog and the CODEX
      with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment,
      in order to determine if the patients have cognitive impairments, to evaluate the sensitivity
      of these 4 screening tests in elderly patients seeking treatment for their cancer. The
      results of this study will make it possible, where appropriate, to adapt the practice in the
      context of oncogeriatric assessment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Passation of MMS and MoCA tests associated to passation of neuropsychological test
primary purpose: Other
masking: Single (Participant)
measure: Evaluate the sensitivity of MoCA test
time frame: Up 2 months after inclusion, before initiation of treatment
description: MoCA is considered clinically relevant if its sensitivity to identify patients with cognitive impairment is at least 75%
intervention type: Other
intervention name: Passation of neuropsychological test
description: Passation of MoCA and MMS tests associated with neuropsychological test
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: florence JOLY, prof
role: Principal Investigator
affiliation: Centre François Baclesse
last name: Florence JOLY, Prof
phone: 0231455050
email: f.joly@baclesse.unicancer.fr
last name: Marie LANGE
email: m.lange@baclesse.unicancer.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
mesh term: Cognition Disorders
sharing ipd: No