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Cell-free RNA signature for Diagnosis and Personalized Therapeutics in Children with Kawasaki Disease

Award Number: R01HL179031
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2028

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Cell-free RNA signature for Diagnosis and Personalized Therapeutics in Children with Kawasaki Disease - Abstract Kawasaki disease (KD) is the most common cause of pediatric acquired heart disease whose etiology remains unknown and for which there is no diagnostic test. Coronary artery aneurysms (CAA) are the feared complication for which intensification of initial therapy may mitigate the damage to the arterial wall. Clinical scoring systems have failed to achieve desired predictive accuracy. We propose cell-free (cf) RNA as a novel biomarker discovery platform to diagnose KD and to predict the development of CAA and resistance to the standard treatment with intravenous immunoglobulin (IVIG). A predictive signature would facilitate a personalized medicine approach to select patients who could benefit from early administration of adjunctive therapies. This proposal brings together three teams with established collaborations (the clinical and translational science team at UCSD (Burns, Tremoulet, and Shimizu), the bioinformatics team at Yale (Kim), and the cfRNA team at Cornell (DeVlaminck)) to tackle an unmet clinical need: the accurate diagnosis of KD and prediction of aneurysm risk and IVIG resistance (IVIG-R). We will be the first to analyze circulating cfRNA from acute and subacute KD plasma. While whole blood RNA is largely released from live, healthy cells, cfRNA is released by dying or rapidly turning over cells in tissues and can therefore reveal information about pathways of cell death and tissue injury. We will deconvolute the cfRNA to identify the cell type of origin that we postulate will show differences between patients who do or do not develop CAA and those who are IVIG- responsive or resistant. We will first analyze plasma from a combined retrospective (banked) and prospective cohort of KD (n=711) and febrile controls (n=695) to develop a diagnostic signature of KD that can be adapted to a PCR-based assay suitable for the hospital laboratory. From the 711 acute KD subjects we will identify cfRNA signatures that predict CAA and IVIG-R. In a second aim, we will analyze pre- and post-treatment cfRNA to determine changes in the molecular signatures as a function of different treatments. All patients receive IVIG and a subset receive other immunomodulatory agents as intensification of their initial therapy. Because clinical trials of different adjunctive therapies are not feasible in this rare disease population, we will analyze pre- and post-treatment molecular signatures to gain insight into the mechanism of action of these different treatments. Finally, we will test our cfRNA signatures for diagnosis and disease outcome in a prospective cohort (120 KD and 120 febrile controls) that we will enroll in Years 3 and 4 of the study. The prospective cohorts justify the request for five years of support. This innovative proposal will be the first to generate cfRNA data linked to extensive clinical meta-data to create PCR-based molecular signatures that can be translated to improve timely diagnosis and personalized treatment for KD patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,639,166 )
2026	2026	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Cardiovascular Diseases Research	000	1	9/14/2026	NEW	$1,639,166
														Subtotal = $1,639,166

Grand Total All Awards = $1,639,166

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Cell-free RNA signature for Diagnosis and Personalized Therapeutics in Children with Kawasaki Disease

Award Number: R01HL179031

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2028

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