dbGaP Study Accession: phs002609

NIH Institute/Center: NICHD

RADx Data Program: RADx-rad

DOI: 10.60773/jcap-3849

Release Date: 11/07/2022

Study Description: The purpose of this study was to develop a tool that can diagnose multisystem inflammatory syndrome in children (MIS-C.) Some children and young adults who have had COVID-19 develop this rare disease about a month after they recover. It can be serious, as it causes inflammation in various organs, including the heart, lungs, kidneys, brain, skin, eyes, and intestines. MIS-C has symptoms similar to several diseases, including COVID-19 and Kawasaki disease, making diagnosis difficult. Currently, patients must undergo a battery of tests in order to diagnose MIS-C, including bloodwork, x-rays, and echocardiograms, which can take several days, delay treatment, and subject parents and children to the anxiety that's associated with an undiagnosed, concerning illness. The new diagnostic test used an existing invention, a Grating-Coupled Fluorescence Plasmonic (GCFP) chip. It's a small gold chip that can analyze up to 400 biomarkers at once, whereas common methods are only able to analyze one biomarker at a time. The hope was to identify biomarkers that are only present, or are present in higher or lower numbers, when someone has MIS-C. The ability to include multiple biomarkers on one chip was very powerful, as several biomarkers were likely involved with this disease. The ability to identify these biomarkers would enable doctors to place a drop of a patient's saliva or blood on the chip, and the chip will quickly tell them if they have MIS-C or something else that looks like MIS-C. Participants were recruited at four hospitals in the U.S. and Colombia, collecting their blood, saliva, and health information, and followed them for up to four years. Scientists at five laboratories studied the blood and saliva to identify biomarkers, and also studied the microbiome to better understand why some children develop MIS-C or become seriously ill, and others do not.

Updated Date: 01/18/2024

Principal Investigator: Salazar, Juan C

Has Data Files: No

Study Domain: Multisystem Inflammatory Syndrome (MIS); Multisystem Inflammatory Syndrome in Children (MIS-C)

Data Collection Method: Molecular Nucleic Acid or PCR Testing Device

Keywords: Immunology; Microbiome; Pediatrics

Study Design: Case-Control

Multi-Center Study: Yes

Study Sites: The Jackson Laboratory; Health Research; Inc./NYS Department of Health; University of Connecticut; Centro de Estudios en Infectología Pediátrica; NYU Grossman School of Medicine

Data Types: Clinical; Electronic Medical Records; Genomic; Questionnaire or Survey

Study Start Date: 01/01/2021

Study End Date: 11/30/2022

Species: Human Data

Estimated Cohort Size: 660

Study Population Focus: Children

Publication URL: https://pubmed.ncbi.nlm.nih.gov/34382611/; https://pubmed.ncbi.nlm.nih.gov/34528661/; https://pubmed.ncbi.nlm.nih.gov/35963365/; https://pubmed.ncbi.nlm.nih.gov/37064248/

Acknowledgement Statement: This study was supported through funding, 3R61HD105613-02S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-rad program. The study was conducted in collaboration with Connecticut Children's Medical Center, the University of Connecticut, Centro de Estudios en Infectología Pediátrica, the Jackson Laboratories, the New York Department of Health, and New York University. Approved users should acknowledge the provision of data access by dbGaP for accession phs002609.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-272

NIH Grant or Contract Number(s): 3R61HD105613-02S1

Consent/Data Use Limitations: General Research Use