Clinical trial NCT04445402: Pediatrics HOT COVID-19 Database in NY Tristate
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cancer
Immune System Disorder
COVID-19
Hemoglobinopathies
Keywords: Immune System Disorder in Children
Immune System Disorder In Young Adults
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 77
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children from birth to 21 years who have a hematologic, oncologic or stem cell transplant diagnosis and have been tested for COVID-19

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of tristate area pediatric HOT patients tested for COVID-19 that completed 1 year follow-up
timeFrame: One year
Secondary outcomes:
measure: Change in PROMIS T-score
timeFrame: Baseline, 3 Months, 6 Months
measure: Number of collected and analyzed stool samples
timeFrame: Up to one year
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Prakash Satwani, MD
role: PRINCIPAL_INVESTIGATOR
References: