A Blood Test to Diagnose Kawasaki Disease

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Brief Title

A Blood Test to Diagnose Kawasaki Disease

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

Diagnosis of Kawasaki Disease

Secondary Outcome

 Coronary artery status

Condition

Kawasaki Disease


Study Arms / Comparison Groups

 Cohort A
Description:  Blood specimen collection. Study samples must be collected prior to any treatment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

800

Start Date

May 2022

Completion Date

December 2023

Primary Completion Date

December 2022

Eligibility Criteria

        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
      

Gender

All

Ages

6 Months - 5 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Hao Zhang, M.D, 6504279198, [email protected]



Administrative Informations


NCT ID

NCT05091229

Organization ID

KD_001


Responsible Party

Principal Investigator

Study Sponsor

HBI Solutions Inc.

Collaborators

 Shanghai Children's Medical Center

Study Sponsor

Hao Zhang, M.D, Principal Investigator, Shanghai Children's Medical Center


Verification Date

March 2022