A Blood Test to Diagnose Kawasaki Disease

NCT ID: NCT05091229

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-12-31

Brief Summary

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.

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.

Conditions

Kawasaki Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A

Blood specimen collection. Study samples must be collected prior to any treatment.

No interventions assigned to this group

Cohort B

Blood specimen collection. Study samples must be collected prior to any treatment.

No interventions assigned to this group

Cohort C

Blood specimen collection. Study samples must be collected prior to any treatment.

No interventions assigned to this group

Eligibility Criteria

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

• 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

• 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

COHORT B

• 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

• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Children's Medical Center

OTHER

Sponsor Role: collaborator

mProbe Inc.

INDUSTRY

Sponsor Role: collaborator

HBI Solutions Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Hao Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hao Zhang, M.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Medical Center

Central Contacts

James Schilling

Role: CONTACT

admin@mprobe.com

6504279198

Other Identifiers

KD_001

Identifier Type: -

Identifier Source: org_study_id