<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/NCT04433871</url>
  </required_header>
  <id_info>
    <org_study_id>20-065</org_study_id>
    <nct_id>NCT04433871</nct_id>
  </id_info>
  <brief_title>COVID-19 in Pediatric Oncology and Hematology Centers in France</brief_title>
  <acronym>PEDONCOVID</acronym>
  <official_title>National SFCE Cohort of SARS-CoV-2 Infections (COVID-19) in Pediatric Oncology and Hematology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Since the description of the first cases of infection in December 2019 in the Hubei province&#xD;
      in China, a new coronavirus, called SARS-CoV-2 (severe acute respiratory syndrome coronavirus&#xD;
      2), emerged and caused a pandemic. This new virus is responsible for an infectious disease&#xD;
      with respiratory and potent severe symptoms, called COVID-19 (coronavirus disease 2019). The&#xD;
      first data concerned essentially the adult population and gave a clinical description of the&#xD;
      disease. However, data is missing in the pediatric population. The first published studies&#xD;
      indicate that children seem to have a lower risk to get a severe form of COVID-19. Except the&#xD;
      case of a child with leukemia recently described with the diagnosis of COVID-19, there is&#xD;
      currently no data about pediatric patients with an oncology history or under chemotherapeutic&#xD;
      drugs. Cancers are rare among children and is estimated to concern about 1700 new cases in a&#xD;
      year in France. Malignant tumor or its treatment can affect self-immunity, which could favor&#xD;
      SARS-CoV-2 infection or its aggravation. Thus, the investigators propose in this study to&#xD;
      collect data about French children with a cancer and diagnosed with COVID-19.The analysis of&#xD;
      the collected data will refine clinical characteristics of SARS-CoV-2 infection in this&#xD;
      population. It will be critical for elaborating recommendations for the management of&#xD;
      COVID-19 in children with cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the description of the first cases in December 2019, the world is facing the emergence&#xD;
      of a new coronavirus called &quot;severe acute respiratory syndrome coronavirus 2&quot; (SARS-CoV-2),&#xD;
      which is responsible for an infectious disease mainly with respiratory manifestation and&#xD;
      potently severe or even lethal, named coronavirus disease 2019 (COVID-19) (N. Zhu et al.&#xD;
      2020; Huang et al. 2020). The global spread of this virus led to the development of an&#xD;
      unprecedented pandemic with an huge impact on public health and from a social and economic&#xD;
      point of view (Ayittey et al. 2020).&#xD;
&#xD;
      First published data mainly concerned the adult population with a detailed COVID-19 clinical&#xD;
      description. Few data are available in children. However, the first studies suggest that&#xD;
      children may be at a lower risk than adults of developing a severe form of COVID-19 (Guan et&#xD;
      al. 2020; Lu et al. 2020; Sinha et al. 2020). Neonatal presentation may be more severe (H.&#xD;
      Zhu et al. 2020). Children seem to present with similar symptoms compared with adults but&#xD;
      often with a milder form (Cao et al. 2020). Radiological findings also appear to be similar&#xD;
      to those in adults (Liu et al. 2020; Xia et al. 2020). Children may be asymptomatic and may&#xD;
      participate in the spread of SARS-CoV-2 (Lu et al. 2020; Chan et al. 2020). Nevertheless,&#xD;
      severe COVID-19 forms were described in children, even if deaths remain extremely rare (Sun&#xD;
      et al. 2020; Lu et al. 2020). Among the previous described severe forms, one of the patient&#xD;
      dependent on mechanic ventilation had acute lymphoblastic leukemia (Sun et al. 2020). The&#xD;
      publication of Lu et al. probably refers to this patient and it appears that this patient was&#xD;
      receiving a maintenance treatment (Lu et al. 2020). This patient presented a co-infection&#xD;
      with influenza virus, which probably explained his aggravation (Sun et al. 2020).&#xD;
&#xD;
      To describe COVID-19 presentation in children, adolescent and young adults, this study will&#xD;
      include all patients with the following criteria:&#xD;
&#xD;
      - Patient followed-up in any French pediatric oncology and hematology center for a cancer or&#xD;
      a benign tumor treated with chemotherapy, radiotherapy or a targeted therapy and with an&#xD;
      oncologic treatment ongoing or terminated within the last 6 months, or with an hematopoietic&#xD;
      stem cell transplantation history with an immunosuppressive treatment ongoing or terminated&#xD;
      within the last 6 months, or a CAR-T cell therapy history&#xD;
&#xD;
      AND&#xD;
&#xD;
      - PCR or serologically-confirmed SARS-CoV-2 infection&#xD;
&#xD;
      OR&#xD;
&#xD;
      -Clinical and radiological diagnosis of SARS-CoV-2 infection with the following criteria : At&#xD;
      least two of the following signs (three if no history of contact with an individual with a&#xD;
      confirmed COVID-19): fever, cough, loss of smell, loss of taste, myalgia, chest pain, breath&#xD;
      shortness, rhinorrhea, acute respiratory signs, diarrhea, headache, recent lethargy, skin&#xD;
      rash.&#xD;
&#xD;
      AND&#xD;
&#xD;
      - At least one abnormality compatible with COVID-19 on a chest computed tomography scan.&#xD;
&#xD;
      In all included patients, the following informations will be retrieved from their medical&#xD;
      record :&#xD;
&#xD;
        -  socio-demographic and anthropometric data: age, sex, weight, height...&#xD;
&#xD;
        -  cancer history: type of cancer, severity, ongoing or 30-days past oncologic treatment,&#xD;
           significant oncologic treatment with potent impact on COVID-19 evolution (lung surgery,&#xD;
           lung radiotherapy...)&#xD;
&#xD;
        -  clinical symptoms at initial stage, at 10-15, 15-20, 20-30 days of evolution&#xD;
&#xD;
        -  biological signs at initial stage, at 10-15, 15-20, 20-30 days of evolution&#xD;
&#xD;
        -  radiological signs at initial stage and on the following exams&#xD;
&#xD;
        -  COVID-19 management data: oxygen, antiviral agents, antibiotics...&#xD;
&#xD;
        -  Evolutive data: resolution/aggravation of infection, potent sequelae...&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 27, 2020</start_date>
  <completion_date type="Anticipated">April 27, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 27, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Oncologic data</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Type of cancer and/or underlying pathologies, oncologic treatments administrated before COVID-19 diagnosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19 diagnosis</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Date of COVID-19 diagnosis, method of diagnosis (PCR and/or clinical signs and/or serology)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical signs</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Description of clinical signs at initial phase, days 7-10, days 15-20 and days 25-30</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biological signs</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Description of biological signs at initial phase, days 7-10, days 15-20 and days 25-30</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiological signs</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>chest X-rays and/or CT-scan description if performed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19 management</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Management in hospital or at home, use of specific drugs against SARS-CoV2, oxygen required or not, other drugs administrated to manage infection complications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potent COVID-19 sequelae</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>type of sequelae if any</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Covid-19</condition>
  <condition>Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention, observational</intervention_name>
    <description>No intervention, observational</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children or young adult with a recent oncologic history diagnosed with COVID-19.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and parents or adult patient informed AND&#xD;
&#xD;
          -  Patient followed-up in a French SFCE pediatric oncology and/or hematology center AND&#xD;
&#xD;
          -  Patient followed-up for a cancer or a benign tumor treated with chemotherapy,&#xD;
             radiotherapy or targeted therapy and an oncologic treatment ongoing or terminated less&#xD;
             than 6 months ago, or patient with an history of hematopoietic stem cells&#xD;
             transplantation with immunosuppressive treatment ongoing or terminated less than 6&#xD;
             month ago, or patient with history of CAR-T cell therapy AND&#xD;
&#xD;
          -  SARS-CoV-2 infection confirmed by PCR or IgM positivity OR&#xD;
&#xD;
          -  Compatible diagnosis of SARS-CoV-2 infection without biological confirmation if: 1-&#xD;
             presence of at least two of the following clinical signs if any contact with a COVID+&#xD;
             subject or three of the following clinical signs in case of no such contact: fever,&#xD;
             cough, taste or smell abnormality, myalgia, rhinorrhea, diarrhea, respiratory acute&#xD;
             signs, recent fatigue, rash, chest pain. AND&#xD;
&#xD;
          -  At least one chest CT-scan abnormality compatible with COVID-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  opposition of the patient or of the parents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>30 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jérémie Rouger-Gaudichon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Caen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jérémie M Rouger-Gaudichon, MD, PhD</last_name>
    <phone>+33231064488</phone>
    <email>rouger-j@chu-caen.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jérémie Rouger-Gaudichon</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jérémie M Rouger-Gaudichon, MD, PhD</last_name>
      <phone>0231064488</phone>
      <email>rouger-j@chu-caen.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>April 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>child</keyword>
  <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/NCT04433871
org study id: 20-065
nct id: NCT04433871
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Since the description of the first cases of infection in December 2019 in the Hubei province
      in China, a new coronavirus, called SARS-CoV-2 (severe acute respiratory syndrome coronavirus
      2), emerged and caused a pandemic. This new virus is responsible for an infectious disease
      with respiratory and potent severe symptoms, called COVID-19 (coronavirus disease 2019). The
      first data concerned essentially the adult population and gave a clinical description of the
      disease. However, data is missing in the pediatric population. The first published studies
      indicate that children seem to have a lower risk to get a severe form of COVID-19. Except the
      case of a child with leukemia recently described with the diagnosis of COVID-19, there is
      currently no data about pediatric patients with an oncology history or under chemotherapeutic
      drugs. Cancers are rare among children and is estimated to concern about 1700 new cases in a
      year in France. Malignant tumor or its treatment can affect self-immunity, which could favor
      SARS-CoV-2 infection or its aggravation. Thus, the investigators propose in this study to
      collect data about French children with a cancer and diagnosed with COVID-19.The analysis of
      the collected data will refine clinical characteristics of SARS-CoV-2 infection in this
      population. It will be critical for elaborating recommendations for the management of
      COVID-19 in children with cancer.
Since the description of the first cases in December 2019, the world is facing the emergence
      of a new coronavirus called "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2),
      which is responsible for an infectious disease mainly with respiratory manifestation and
      potently severe or even lethal, named coronavirus disease 2019 (COVID-19) (N. Zhu et al.
      2020; Huang et al. 2020). The global spread of this virus led to the development of an
      unprecedented pandemic with an huge impact on public health and from a social and economic
      point of view (Ayittey et al. 2020).

      First published data mainly concerned the adult population with a detailed COVID-19 clinical
      description. Few data are available in children. However, the first studies suggest that
      children may be at a lower risk than adults of developing a severe form of COVID-19 (Guan et
      al. 2020; Lu et al. 2020; Sinha et al. 2020). Neonatal presentation may be more severe (H.
      Zhu et al. 2020). Children seem to present with similar symptoms compared with adults but
      often with a milder form (Cao et al. 2020). Radiological findings also appear to be similar
      to those in adults (Liu et al. 2020; Xia et al. 2020). Children may be asymptomatic and may
      participate in the spread of SARS-CoV-2 (Lu et al. 2020; Chan et al. 2020). Nevertheless,
      severe COVID-19 forms were described in children, even if deaths remain extremely rare (Sun
      et al. 2020; Lu et al. 2020). Among the previous described severe forms, one of the patient
      dependent on mechanic ventilation had acute lymphoblastic leukemia (Sun et al. 2020). The
      publication of Lu et al. probably refers to this patient and it appears that this patient was
      receiving a maintenance treatment (Lu et al. 2020). This patient presented a co-infection
      with influenza virus, which probably explained his aggravation (Sun et al. 2020).

      To describe COVID-19 presentation in children, adolescent and young adults, this study will
      include all patients with the following criteria:

      - Patient followed-up in any French pediatric oncology and hematology center for a cancer or
      a benign tumor treated with chemotherapy, radiotherapy or a targeted therapy and with an
      oncologic treatment ongoing or terminated within the last 6 months, or with an hematopoietic
      stem cell transplantation history with an immunosuppressive treatment ongoing or terminated
      within the last 6 months, or a CAR-T cell therapy history

      AND

      - PCR or serologically-confirmed SARS-CoV-2 infection

      OR

      -Clinical and radiological diagnosis of SARS-CoV-2 infection with the following criteria : At
      least two of the following signs (three if no history of contact with an individual with a
      confirmed COVID-19): fever, cough, loss of smell, loss of taste, myalgia, chest pain, breath
      shortness, rhinorrhea, acute respiratory signs, diarrhea, headache, recent lethargy, skin
      rash.

      AND

      - At least one abnormality compatible with COVID-19 on a chest computed tomography scan.

      In all included patients, the following informations will be retrieved from their medical
      record :

        -  socio-demographic and anthropometric data: age, sex, weight, height...

        -  cancer history: type of cancer, severity, ongoing or 30-days past oncologic treatment,
           significant oncologic treatment with potent impact on COVID-19 evolution (lung surgery,
           lung radiotherapy...)

        -  clinical symptoms at initial stage, at 10-15, 15-20, 20-30 days of evolution

        -  biological signs at initial stage, at 10-15, 15-20, 20-30 days of evolution

        -  radiological signs at initial stage and on the following exams

        -  COVID-19 management data: oxygen, antiviral agents, antibiotics...

        -  Evolutive data: resolution/aggravation of infection, potent sequelae...
observational model: Cohort
time perspective: Prospective
measure: Oncologic data
time frame: through study completion, an average of 1 year
description: Type of cancer and/or underlying pathologies, oncologic treatments administrated before COVID-19 diagnosis.
measure: COVID-19 diagnosis
time frame: through study completion, an average of 1 year
description: Date of COVID-19 diagnosis, method of diagnosis (PCR and/or clinical signs and/or serology)
measure: Clinical signs
time frame: through study completion, an average of 1 year
description: Description of clinical signs at initial phase, days 7-10, days 15-20 and days 25-30
measure: Biological signs
time frame: through study completion, an average of 1 year
description: Description of biological signs at initial phase, days 7-10, days 15-20 and days 25-30
measure: Radiological signs
time frame: through study completion, an average of 1 year
description: chest X-rays and/or CT-scan description if performed
measure: COVID-19 management
time frame: through study completion, an average of 1 year
description: Management in hospital or at home, use of specific drugs against SARS-CoV2, oxygen required or not, other drugs administrated to manage infection complications.
measure: Potent COVID-19 sequelae
time frame: through study completion, an average of 1 year
description: type of sequelae if any
intervention type: Other
intervention name: No intervention, observational
description: No intervention, observational
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 30 Years
last name: Jérémie Rouger-Gaudichon, MD, PhD
role: Principal Investigator
affiliation: University Hospital of Caen
last name: Jérémie M Rouger-Gaudichon, MD, PhD
phone: +33231064488
email: rouger-j@chu-caen.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided