Development of a Novel Scoring System for Predicting Coronary Artery Aneurysm Formation in Kawasaki Disease Using Circulating Cell-Free DNA Analysis

Construction and Clinical Validation of a Molecular Prediction Model for Coronary Artery Aneurysm Formation in Kawasaki Disease Using Circulating Cell-Free DNA Analysis - Construction and Clinical Validation of a Molecular Prediction Model for Coronary Artery Aneurysm Formation in Kawasaki Disease Using Circulating Cell-Free DNA Analysis(K-CAARE Study)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057613

Enrollment

500

Registered

2025-05-27

Start date

2025-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kawasaki disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pediatric patients under 18 years of age diagnosed with Kawasaki disease Availability of stored plasma samples collected within 10 days of disease onset (acute phase) Echocardiographic assessment of coronary arteries has been performed Written informed consent has been obtained from the patient or their legal guardian

Exclusion criteria

Exclusion criteria: Patients for whom only chronic-phase plasma samples are available Presence of comorbid conditions that may affect cfDNA levels, such as hematologic disorders, malignancies, or autoimmune diseases Incomplete echocardiographic data or inadequate coronary artery assessment Inability to obtain written informed consent Cases with insufficient clinical information that precludes analysis

Design outcomes

Primary

Measure	Time frame
Predictive accuracy of cfDNA-based risk estimation for coronary artery aneurysm (CAA) formation Area Under the Curve (AUC) from Receiver Operating Characteristic (ROC) analysis Identification of disease-specific epigenetic alterations in cfDNA profiles Changes in chromatin accessibility and transcription factor binding sites Clinical validation of the constructed prediction model Reproducibility and predictive performance in retrospective and prospective cohorts	—

Measure

Time frame

Predictive accuracy of cfDNA-based risk estimation for coronary artery aneurysm (CAA) formation Area Under the Curve (AUC) from Receiver Operating Characteristic (ROC) analysis Identification of disease-specific epigenetic alterations in cfDNA profiles Changes in chromatin accessibility and transcription factor binding sites Clinical validation of the constructed prediction model Reproducibility and predictive performance in retrospective and prospective cohorts

—

Countries

Japan,Asia(except Japan),North America

Contacts

Public ContactTakanori Suzuki

Fujita health university Pediatrics

takanori-s@axel.ocn.ne.jp0562-93-9251

Outcome results