<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/NCT04445870</url>
  </required_header>
  <id_info>
    <org_study_id>2020Ao001*</org_study_id>
    <nct_id>NCT04445870</nct_id>
  </id_info>
  <brief_title>Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study</brief_title>
  <acronym>ONCOCARE-COV</acronym>
  <official_title>Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</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>
      In december 2019, SARS-CoV2 and its clinical manifestations, COVID-19, appeared in China and&#xD;
      caused a pandemic. It led decision makers to prioritize emergency and intensive care&#xD;
      dedicated to infection management. Other conditions, such as cancer screening, diagnosis, and&#xD;
      treatment, may have been delayed during the containment period. Consequences of this&#xD;
      &quot;distraction effect&quot; are being.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Quantitative monthly data were analyzed from January 1, 2019 to May 31, 2020 in two French&#xD;
      tertiary care center (University Hospital and Godinot Cancer Institute in Reims) and in a&#xD;
      third center in the French epicenter (Colmar hospital). Oncologic activity indicators were&#xD;
      extracted using oncologic electronic file, International Statistical Classification of&#xD;
      Diseases and Related Health Problems, Tenth Revision (ICD-10) and nation-wide procedure codes&#xD;
      (CCAM). The monthly number of different steps of oncology care pathway (screening, diagnosis&#xD;
      and treatment) were collected: faecal immunochemical testing (FIT), mammography,&#xD;
      histopathological and biomolecular/genetics analysis, nuclear medicine imaging, oncogeriatric&#xD;
      evaluations, multidisciplinary tumor board meetings and files reviewed by meeting including&#xD;
      first presentations, given personalized care program, medical announcement and reformulation&#xD;
      nursing consultations, inserted central venous catheters, chemotherapy prepared and&#xD;
      administered in chemotherapy day care, carcinologic surgeries and radiotherapy courses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>data record</measure>
    <time_frame>from 01/01/2019 to 31/12/2020</time_frame>
    <description>faecal immunochemical testing (FIT), mammography, histopathological and biomolecular/genetics analysis, nuclear medicine imaging, oncogeriatric evaluations, multidisciplinary tumor board meetings and files reviewed by meeting including first presentations, given personalized care program, medical announcement and reformulation nursing consultations, inserted central venous catheters, chemotherapy prepared and administered in chemotherapy day care, carcinologic surgeries and radiotherapy courses.</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data record</intervention_name>
    <description>Data record on registers without medical files</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patient entering an oncology care pathway&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Every adult patient entering an oncology care pathway between 01/01/2019 and&#xD;
             31/12/2020&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 yo&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 8, 2022</last_update_submitted>
  <last_update_submitted_qc>July 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04445870
org study id: 2020Ao001*
nct id: NCT04445870
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In december 2019, SARS-CoV2 and its clinical manifestations, COVID-19, appeared in China and
      caused a pandemic. It led decision makers to prioritize emergency and intensive care
      dedicated to infection management. Other conditions, such as cancer screening, diagnosis, and
      treatment, may have been delayed during the containment period. Consequences of this
      "distraction effect" are being.
Quantitative monthly data were analyzed from January 1, 2019 to May 31, 2020 in two French
      tertiary care center (University Hospital and Godinot Cancer Institute in Reims) and in a
      third center in the French epicenter (Colmar hospital). Oncologic activity indicators were
      extracted using oncologic electronic file, International Statistical Classification of
      Diseases and Related Health Problems, Tenth Revision (ICD-10) and nation-wide procedure codes
      (CCAM). The monthly number of different steps of oncology care pathway (screening, diagnosis
      and treatment) were collected: faecal immunochemical testing (FIT), mammography,
      histopathological and biomolecular/genetics analysis, nuclear medicine imaging, oncogeriatric
      evaluations, multidisciplinary tumor board meetings and files reviewed by meeting including
      first presentations, given personalized care program, medical announcement and reformulation
      nursing consultations, inserted central venous catheters, chemotherapy prepared and
      administered in chemotherapy day care, carcinologic surgeries and radiotherapy courses.
observational model: Other
time perspective: Retrospective
measure: data record
time frame: from 01/01/2019 to 31/12/2020
description: faecal immunochemical testing (FIT), mammography, histopathological and biomolecular/genetics analysis, nuclear medicine imaging, oncogeriatric evaluations, multidisciplinary tumor board meetings and files reviewed by meeting including first presentations, given personalized care program, medical announcement and reformulation nursing consultations, inserted central venous catheters, chemotherapy prepared and administered in chemotherapy day care, carcinologic surgeries and radiotherapy courses.
intervention type: Other
intervention name: data record
description: Data record on registers without medical files
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided