<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/NCT04445402</url>
  </required_header>
  <id_info>
    <org_study_id>AAAT0268</org_study_id>
    <nct_id>NCT04445402</nct_id>
  </id_info>
  <brief_title>Pediatrics HOT COVID-19 Database in NY Tristate</brief_title>
  <official_title>Retrospective and Prospective Database of COVID-19 Prevalence and Clinical Course in Pediatric and Young Adult Hematology/ Oncology/Stem Cell Therapy Patients in the New York Tri-State Area.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</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>
      New York City (NYC) has become the epicenter of the worldwide pandemic caused by severe acute&#xD;
      respiratory syndrome coronavirus-2 (SARS-CoV-2). By collecting and summarizing the experience&#xD;
      with other major health care providers in the tristate (New York (NY), New Jersey (NJ) and&#xD;
      Connecticut (CT)) are, the investigators are uniquely positioned to inform the rest of the&#xD;
      country about what to expect and how to manage children and young adults with hematological,&#xD;
      oncological or stem cell transplant diagnoses during the pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects are all pediatric hematology, oncology or stem cell transplant (HOT) children&#xD;
      and young adults who are tested for SARS-CoV-2. The investigators will collect data including&#xD;
      demographics, clinical characteristics, clinical courses, outcomes from the medical record.&#xD;
&#xD;
      Other information about finances, mental health, and nutrition will be ascertained by&#xD;
      questionnaires. The subjects will be asked to allow the researchers to abstract information&#xD;
      from their medical record, participate in an interview or telephone call (their choice) to&#xD;
      answer questionnaires, and to provide a stool sample at three time points.&#xD;
&#xD;
      The creation of an integrated database of COVID-19 pediatric and young adult patients will&#xD;
      better inform the pediatric hematology, oncology, and stem cell transplant community about&#xD;
      this disease specifically related to patients undergoing HOT therapy and provide valuable&#xD;
      evidence to develop standardized and clinically appropriate approaches to their care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2020</start_date>
  <completion_date type="Actual">September 12, 2022</completion_date>
  <primary_completion_date type="Actual">September 12, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Number of tristate area pediatric HOT patients tested for COVID-19 that completed 1 year follow-up</measure>
    <time_frame>One year</time_frame>
    <description>To measure the success of the data registry in how many patients agreed to participate and completed the one year follow up. A confirmed case of COVID-19 is defined as a positive result on a reverse-transcriptase- polymerase-chain-reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab, or a serum antibody test. Only laboratory-confirmed cases will be described as positive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS T-score</measure>
    <time_frame>Baseline, 3 Months, 6 Months</time_frame>
    <description>To analyze effect of COVID-19 on patients and their families mental health. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of collected and analyzed stool samples</measure>
    <time_frame>Up to one year</time_frame>
    <description>To examine if the pandemic has effects on the patients' nutrition and microbiome. Each patient is given an opportunity to provide stool samples in addition to survey response.</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">77</enrollment>
  <condition>Pediatric Cancer</condition>
  <condition>Immune System Disorder</condition>
  <condition>COVID-19</condition>
  <condition>Hemoglobinopathies</condition>
  <arm_group>
    <arm_group_label>Heme/Non-Sickle Cell Disease</arm_group_label>
    <description>Subjects with a diagnosis of hemoglobinapathy except Sickle Cell Disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heme/Sickle Cell Disease</arm_group_label>
    <description>Subjects with a diagnosis of Sickle Cell Disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neuro-Oncological Disease</arm_group_label>
    <description>Oncology diagnosis with involvement of the neurological system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oncology/Non-Neuro-Oncological</arm_group_label>
    <description>Subjects with any oncology diagnosis except those that involve the neurological system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transplant patients</arm_group_label>
    <description>Subjects who have received or are intending to have a stem cell transplant for treatment of disease.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Optional stool specimens may be collected at three time points: 1) at diagnosis, 2) at&#xD;
      resolution of COVID-19, 3) and at six months post-diagnosis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children from birth to 21 years who have a hematologic, oncologic or stem cell transplant&#xD;
        diagnosis and have been tested for COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hematologic, Oncologic or Stem Cell Transplant Diagnosis&#xD;
&#xD;
          -  Tested for COVID-19&#xD;
&#xD;
          -  Age up to 21 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prakash Satwani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>April 28, 2023</last_update_submitted>
  <last_update_submitted_qc>April 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immune System Disorder in Children</keyword>
  <keyword>Immune System Disorder In Young Adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Hemoglobinopathies</mesh_term>
    <mesh_term>Immune System Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT04445402
org study id: AAAT0268
nct id: NCT04445402
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
New York City (NYC) has become the epicenter of the worldwide pandemic caused by severe acute
      respiratory syndrome coronavirus-2 (SARS-CoV-2). By collecting and summarizing the experience
      with other major health care providers in the tristate (New York (NY), New Jersey (NJ) and
      Connecticut (CT)) are, the investigators are uniquely positioned to inform the rest of the
      country about what to expect and how to manage children and young adults with hematological,
      oncological or stem cell transplant diagnoses during the pandemic.
The subjects are all pediatric hematology, oncology or stem cell transplant (HOT) children
      and young adults who are tested for SARS-CoV-2. The investigators will collect data including
      demographics, clinical characteristics, clinical courses, outcomes from the medical record.

      Other information about finances, mental health, and nutrition will be ascertained by
      questionnaires. The subjects will be asked to allow the researchers to abstract information
      from their medical record, participate in an interview or telephone call (their choice) to
      answer questionnaires, and to provide a stool sample at three time points.

      The creation of an integrated database of COVID-19 pediatric and young adult patients will
      better inform the pediatric hematology, oncology, and stem cell transplant community about
      this disease specifically related to patients undergoing HOT therapy and provide valuable
      evidence to develop standardized and clinically appropriate approaches to their care.
observational model: Other
time perspective: Prospective
measure: Number of tristate area pediatric HOT patients tested for COVID-19 that completed 1 year follow-up
time frame: One year
description: To measure the success of the data registry in how many patients agreed to participate and completed the one year follow up. A confirmed case of COVID-19 is defined as a positive result on a reverse-transcriptase- polymerase-chain-reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab, or a serum antibody test. Only laboratory-confirmed cases will be described as positive.
measure: Change in PROMIS T-score
time frame: Baseline, 3 Months, 6 Months
description: To analyze effect of COVID-19 on patients and their families mental health. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
measure: Number of collected and analyzed stool samples
time frame: Up to one year
description: To examine if the pandemic has effects on the patients' nutrition and microbiome. Each patient is given an opportunity to provide stool samples in addition to survey response.
arm group label: Heme/Non-Sickle Cell Disease
description: Subjects with a diagnosis of hemoglobinapathy except Sickle Cell Disease
arm group label: Heme/Sickle Cell Disease
description: Subjects with a diagnosis of Sickle Cell Disease
arm group label: Neuro-Oncological Disease
description: Oncology diagnosis with involvement of the neurological system
arm group label: Oncology/Non-Neuro-Oncological
description: Subjects with any oncology diagnosis except those that involve the neurological system.
arm group label: Transplant patients
description: Subjects who have received or are intending to have a stem cell transplant for treatment of disease.
Optional stool specimens may be collected at three time points: 1) at diagnosis, 2) at
      resolution of COVID-19, 3) and at six months post-diagnosis.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
last name: Prakash Satwani, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Hemoglobinopathies
mesh term: Immune System Diseases