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Pediatrics HOT COVID-19 Database in NY Tristate

Sponsor
Columbia University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04445402
Collaborator
(none)
1,500
Enrollment
17
Locations
24
Anticipated Duration (Months)
88.2
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    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.
    Actual Study Start Date :
    Apr 30, 2020
    Anticipated Primary Completion Date :
    May 1, 2021
    Anticipated Study Completion Date :
    May 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Heme/Non-Sickle Cell Disease

    Subjects with a diagnosis of hemoglobinapathy except Sickle Cell Disease
    Heme/Sickle Cell Disease

    Subjects with a diagnosis of Sickle Cell Disease
    Neuro-Oncological Disease

    Oncology diagnosis with involvement of the neurological system
    Oncology/Non-Neuro-Oncological

    Subjects with any oncology diagnosis except those that involve the neurological system.
    Transplant patients

    Subjects who have received or are intending to have a stem cell transplant for treatment of disease.

    Outcome Measures

    Primary Outcome Measures

    1. Number of tristate area pediatric HOT patients tested for COVID-19 that completed 1 year follow-up [One year]

      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.

    Secondary Outcome Measures

    1. Change in PROMIS T-score [Baseline, 3 Months, 6 Months]

      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.

    2. Number of collected and analyzed stool samples [Up to one year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Hematologic, Oncologic or Stem Cell Transplant Diagnosis

    • Tested for COVID-19

    • Age up to 21 years of age

    Exclusion Criteria:
    • Unwillingness to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Connecticut Children's Hospital Hartford Connecticut United States 06106
    2 Yale New Haven Children's Hospital New Haven Connecticut United States 06510
    3 Hackensack Meridian Health Hackensack New Jersey United States 07601
    4 Steven Halpern Morristown New Jersey United States 07960
    5 Archana Sharma New Brunswick New Jersey United States 08901
    6 Mount Sinai Beth Israel Newark New Jersey United States 07112
    7 St. Joseph's Regional Medical Center, New Jersey Paterson New Jersey United States 07503
    8 Montefiore Medical Center Bronx New York United States 10467
    9 Maimondes Medical Center Brooklyn New York United States 11219
    10 Mount Sinai New York New York United States 10003
    11 NYU Langone Health New York New York United States 10016
    12 Columbia University Irving Medical Center New York New York United States 10032
    13 Stephen Roberts New York New York United States 10065
    14 Weill Cornell Medicine New York New York United States 10065
    15 Cohen Children's Northwell Health Queens New York United States 11040
    16 Stony Brook University Hospital Stony Brook New York United States 11794
    17 Westchester Medical Center Valhalla New York United States 10595

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Principal Investigator: Prakash Satwani, MD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prakash Satwani, Associate Professor of Pediatrics at the Columbia University Medical Center, Columbia University
    ClinicalTrials.gov Identifier:
    NCT04445402
    Other Study ID Numbers:
    • AAAT0268
    First Posted:
    Jun 24, 2020
    Last Update Posted:
    Jun 24, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prakash Satwani, Associate Professor of Pediatrics at the Columbia University Medical Center, Columbia University
    Immune System Disorder in Children
    Immune System Disorder In Young Adults
    Additional relevant MeSH terms:
    COVID-19
    Hemoglobinopathies
    Immune System Diseases

    Study Results

    No Results Posted as of Jun 24, 2020