Pediatrics HOT COVID-19 Database in NY Tristate
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|ClinicalTrials.gov Identifier: NCT04445402|
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
|Condition or disease|
|Pediatric Cancer Immune System Disorder COVID-19 Hemoglobinopathies|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1500 participants|
|Target Follow-Up Duration:||1 Year|
|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 :||April 30, 2020|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2022|
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
Oncology diagnosis with involvement of the neurological system
Subjects with any oncology diagnosis except those that involve the neurological system.
Subjects who have received or are intending to have a stem cell transplant for treatment of disease.
- Number of tristate area pediatric HOT patients tested for COVID-19 that completed 1 year follow-up [ Time Frame: 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.
- Change in PROMIS T-score [ Time Frame: 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.
- Number of collected and analyzed stool samples [ Time Frame: 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445402
|Contact: Prakash Satwani, MDfirstname.lastname@example.org|
|Contact: Jean Sosna, MS RNemail@example.com|
|Principal Investigator:||Prakash Satwani, MD||Columbia University Irving Medical Center|