Characterization of Multisystem Inflammatory Syndrome in Children (MIS-C) and Its Relationship to Kawasaki Disease
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|ClinicalTrials.gov Identifier: NCT04538495|
Recruitment Status : Recruiting
First Posted : September 4, 2020
Last Update Posted : November 16, 2021
|Condition or disease|
|Kawasaki Disease Inflammation|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Characterization of Multisystem Inflammatory Syndrome in Children (MIS-C) and Its Relationship to Kawasaki Disease|
|Actual Study Start Date :||August 1, 2020|
|Actual Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- Collection of clinical data and patient samples from children with MIS-C and KD to [ Time Frame: We will collect demographic and clinical data on all KD patients at participating sites throughout the 8-month study period. ]Collection of clinical data and patient samples from children with MIS-C and KD to understand the relationship between these two conditions.
Biospecimen Retention: Samples With DNA
12.5 cc of blood (2.5 teaspoons) (for RNA studies, plasma protein studies, serum antibody measurement, and in vitro studies of PBMC and cultured HUVECs) will be drawn when phlebotomy is performed for routine clinical care from MIS-C. This will be at 3 timepoints: admission (pre-treatment), after treatment but before discharge, at the clinic visit between 1 to 6 weeks after discharge. Whole blood RNA will be collected in PAXgene tubes.
Rectal swab or stool for SARS-CoV-2 PCR testing in the Burns Lab at UCSD will be collected only once at the time of admission.
For sites able/willing to participate in live cell collection, heparinized blood (green top tubes) for PBMC and neutrophil studies.
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): NCT04538495
|Contact: Jane C Burnsfirstname.lastname@example.org|
|Contact: Adriana H Tremouletemail@example.com|
|Principal Investigator:||Jane C Burns||University of California, San Diego|