A Blood Test to Diagnose Kawasaki Disease

A Cohort Study to Evaluate a Blood Test for Early-screening of Kawasaki Disease

A case-control cohort study is being conducted to develop and validate the performance of a whole blood gene expression qPCR test to distinguish KD from other febrile conditions by collecting whole blood sample from KD patients in the first 7 days of illness and from febrile controls immediately after presentation and before clinical diagnosis is confirmed.

Study Overview

• Status: Not yet recruiting
• Conditions: Kawasaki Disease

Detailed Description

Currently, there is no diagnostic tool for Kawasaki disease (KD). Diagnosis is based on clinical features shared with other febrile conditions, frequently resulting in delayed or missed treatment and an increased risk of coronary artery aneurysms. An accurate diagnostic blood test might enable early discrimination of Kawasaki disease from other infectious and inflammatory conditions, resulting in a precise clinical treatment to improves survival and quality of children's life. The purpose of this study is to develop and validate a blood-based assay for accurate diagnosis of KD in in the first 7 days of illness.

The study will collect blood samples from healthy patients with no recent history of fever or immunization and from febrile patients diagnosed with KD or other infectious and inflammatory diseases.

Three types of patients in this study:

Cohort A:

Children ages 6-60 months old who have been diagnosed with (or strong clinical suspicion for) KD by clinician. Blood samples must be collected before any treatment has been initiated.

Cohort B:

Children ages 6-60 months old with febrile conditions who have been diagnosed with other infections or inflammation by clinician. Blood samples must be collected before any treatment.

Cohort C:

Children ages 6-60 months old with no recent history of fever or immunization.

• Study Type: Observational
• Enrollment (Anticipated): 800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

COHORT A

Inclusion Criteria:

• 6- 60 months of age
• Diagnosed with possible Kawasaki disease (even if they do not fulfil the criteria below for Kawasaki disease) by the treating clinician based on the 2004 AHA guidelines
• Appropriate guardian of patients are able and willing to provide blood samples per protocol
• Appropriate guardian of patients are able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

Exclusion Criteria:

• Patient with comorbidities likely to influence gene expression, such as immunosuppressive treatments,
• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Have participated or be currently participating in a clinical research study in which an experimental medication has been administered

COHORT B

Inclusion Criteria:

• 6- 60 months of age
• Diagnosed with febrile illness but without Kawasaki disease presentation criteria
• Appropriate guardian of patients are able and willing to provide blood samples per protocol
• Appropriate guardian of patients are able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

Exclusion Criteria:

• Patient with comorbidities likely to influence gene expression, such as immunosuppressive treatments,
• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Have participated or be currently participating in a clinical research study in which an experimental medication has been administered

COHORT C

Inclusion Criteria:

• 6- 60 months of age
• no recent history of fever or immunization
• Appropriate guardian of patients are able and willing to provide blood samples per protocol
• Appropriate guardian of patients are able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

Exclusion Criteria:

• Patient with comorbidities likely to influence gene expression, such as immunosuppressive treatments,
• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Have participated or be currently participating in a clinical research study in which an experimental medication has been administered

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Cohort A; Blood specimen collection. Study samples must be collected prior to any treatment.
Cohort B; Blood specimen collection. Study samples must be collected prior to any treatment.
Cohort C; Blood specimen collection. Study samples must be collected prior to any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of Kawasaki Disease	Diagnosis of KD in patients made by KD experts (pediatric infectious disease or pediatric rheumatologists) based on the 2004 AHA guidelines.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coronary artery status	Coronary artery status and Z-score (SD from the mean adjusted for body surface area) for patients with KD, will be recorded. Coronary artery status will be classified as normal (right coronary artery (RCA) and left anterior descending (LAD) Z-score always <2.5) or abnormal (RCA and/or LAD Z-score ≥2.5 within the first 6 weeks after diagnosis).	6 weeks
Coronary artery aneurysm	Echo findings with coronary artery aneurysm	6 weeks

Collaborators and Investigators

• Sponsor: HBI Solutions Inc.
• Collaborators: Shanghai Children's Medical Center; mProbe Inc.
• Investigators: Principal Investigator: Hao Zhang, M.D, Shanghai Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Vasculitis; Skin Diseases, Vascular; Mucocutaneous Lymph Node Syndrome
• Other Study ID Numbers: KD_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No