UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057613 |
|---|---|
| Receipt number | R000065827 |
| Scientific Title | Construction and Clinical Validation of a Molecular Prediction Model for Coronary Artery Aneurysm Formation in Kawasaki Disease Using Circulating Cell-Free DNA Analysis |
| Date of disclosure of the study information | 2025/05/27 |
| Last modified on | 2025/05/27 11:19:17 |
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Basic information
Public title
Development of a Novel Scoring System for Predicting Coronary Artery Aneurysm Formation in Kawasaki Disease Using Circulating Cell-Free DNA Analysis
Acronym
Kawasaki Coronary Artery Aneurysm Risk Estimation using cfDNA (K-CAARE Score)
Scientific Title
Construction and Clinical Validation of a Molecular Prediction Model for Coronary Artery Aneurysm Formation in Kawasaki Disease Using Circulating Cell-Free DNA Analysis
Scientific Title:Acronym
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)
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to construct a novel molecular prediction model (scoring system) for accurately assessing the risk of coronary artery aneurysm formation during the acute phase of Kawasaki disease using circulating cell-free DNA (cfDNA) analysis, and to validate its clinical utility.This model aims to enable early identification of high-risk patients and facilitate timely therapeutic intervention, ultimately contributing to the prevention of coronary complications and improvement of long-term outcomes in Kawasaki disease.
Basic objectives2
Others
Basic objectives -Others
To elucidate disease-specific inflammatory patterns and cellular origins through cfDNA profiling in patients with Kawasaki disease, contributing to better understanding of disease pathophysiology.
To compare cfDNA-based findings with conventional clinical markers and existing biomarkers to assess their predictive superiority or complementary value.
To explore the potential of cfDNA as an early risk stratification tool, paving the way for future personalized medicine in Kawasaki disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | months-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita health University
Division name
Pediatrics
Zip code
4580837
Address
1 98, Dengakugakubo kutsukake, Toyoake, Aichi
TEL
09025786815
takanori-s@axel.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita health university
Division name
Pediatrics
Zip code
4580837
Address
1 98, Dengakugakubo kutsukake, Toyoake, Aichi
TEL
0562-93-9251
Homepage URL
takanori-s@axel.ocn.ne.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1 98, Dengakugakubo kutsukake, Toyoake, Aichi
Tel
0562-93-9251
takanori-s@axel.ocn.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a non-interventional observational study aimed at identifying novel biomarkers and risk stratification methods for Kawasaki disease.
All samples and data will be used following appropriate ethical approvals, with strict attention to the protection of personal information.
The results of this study will be published in academic conferences and peer-reviewed journals.
Management information
Registered date
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065827
