Diagnoses DiseaseNCT05434611
Role of Calcium Binding Protein S100A12 in Diagnosis and Prognosis of Kawasaki Disease
An observational study of Diagnoses Disease, run by The First Affiliated Hospital of Yangtze University.
Trial summary
Recent studies showed that the value of c100A12 increased in children with Kawasaki disease, and decreased rapidly after treatment with gamma globulin. In kawasaki disease with coronary artery dilatation, S100A12 levels are elevated in the acute phase of Kawasaki disease and continue for some time in the convalescence… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diagnoses Disease
- What is being tested?
- S100A12
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The case group consisted of 50 hospitalized children with Kawasaki disease. The healthy control group consisted of 50 healthy children.
Who may be able to join
- ▪Diagnostic criteria of Kawasaki disease revised by the American Heart Association in 2017
Who cannot join
- Scarlet fever
- Drug allergy syndrome
- Stevens-Johnson syndrome
- Toxic shock syndrome
- Adenovirus infection
- Epstein-Barr(EB) virus infection
Trial locations and contacts
No sites are listed yet.
About this study
Recent studies showed that the value of c100A12 increased in children with Kawasaki disease, and decreased rapidly after treatment with gamma globulin. In kawasaki disease with coronary artery dilatation, S100A12 levels are elevated in the acute phase of Kawasaki disease and continue for some time in the convalescence phase before gradually decreasing. However, the number of patients included in previous studies was small and the follow-up time was short. In this study, 100 children with Kawasaki disease who were admitted to Wuhan Children's Hospital, Jingzhou First People's Hospital and Renhe Hospital affiliated to China Three Gorges University from December 2021 to December 2023 were selected as the research objects, and 100 children with healthy physical examination were selected as the control group during the same period. To investigate whether S100A12 increased significantly in the acute phase of Kawasaki disease compared with a healthy control group. To study whether S100A12 value increased rather than decreased in kawasaki disease that did not respond to gamma globulin treatment after gamma globulin treatment. At the same time, to study whether the increase of S100A12 in kawasaki disease convalescence indicates coronary aneurysm.
Read the detailed description
S100A12 was determined using the ELISA kit and according to the instructions.
- Conditions
- Diagnoses Disease
- Being tested
- S100A12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S100A12Diagnostic test
The early dynamic detection of S100A12 was used to determine whether it was an auxiliary diagnostic index for Kawasaki disease
| Study group | Role | What they receive |
|---|---|---|
| Kawasaki disease | All children with Kawasaki disease met the diagnostic criteria for Kawasaki disease revised by the American Heart Association in 2017. Receives: Diagnostic Test: S100A12 | |
| Healthy controls | Healthy control group were healthy children who underwent outpatient physical examination. Receives: Diagnostic Test: S100A12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
S100A12
S100A12 was increased in children with Kawasaki disease and decreased after gamma globulin treatment
Measured: From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months
Secondary outcomes (1)
CRP
Measure the CRP value
Measured: From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Yangtze University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Yan, The First Affiliated Hospital of Yangtze University
- Investigators
- Qihong Fan, Dr., Principal investigator, Yangtze University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434611
- Sponsor's protocol ID
- PYan
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Calcium Binding Protein S100A12 in Diagnosis and Prognosis of Kawasaki Disease
- ClinicalTrials.gov ID
- NCT05434611
- Acronym / sponsor ID
- PYan
- Conditions
- Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Yangtze UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent studies showed that the value of c100A12 increased in children with Kawasaki disease, and decreased rapidly after treatment with gamma globulin. In kawasaki disease with coronary artery dilatation, S100A12 levels are elevated in the acute phase of Kawasaki disease and continue for some time in the convalescence phase before gradually decreasing. However, the number of patients included in previous studies was small and the follow-up time was short. In this study, 100 children with Kawasaki disease who were admitted to Wuhan Children's Hospital, Jingzhou First People's Hospital and Renhe Hospital affiliated to China Three Gorges University from December 2021 to December 2023 were selected as the research objects, and 100 children with healthy physical examination were selected as the control group during the same period. To investigate whether S100A12 increased significantly in the acute phase of Kawasaki disease compared with a healthy control group. To study whether S100A12 value increased rather than decreased in kawasaki disease that did not respond to gamma globulin treatment after gamma globulin treatment. At the same time, to study whether the increase of S100A12 in kawasaki disease convalescence indicates coronary aneurysm.
Detailed description
S100A12 was determined using the ELISA kit and according to the instructions.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kawasaki disease | – | Diagnostic Test: S100A12All children with Kawasaki disease met the diagnostic criteria for Kawasaki disease revised by the American Heart Association in 2017. |
| Healthy controls | – | Diagnostic Test: S100A12Healthy control group were healthy children who underwent outpatient physical examination. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The case group consisted of 50 hospitalized children with Kawasaki disease. The healthy control group consisted of 50 healthy children.
Key inclusion criteria (1 listed)
- ▪Diagnostic criteria of Kawasaki disease revised by the American Heart Association in 2017
Key exclusion criteria (6 listed)
- Scarlet fever
- Drug allergy syndrome
- Stevens-Johnson syndrome
- Toxic shock syndrome
- Adenovirus infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S100A12The early dynamic detection of S100A12 was used to determine whether it was an auxiliary diagnostic index for Kawasaki disease | Diagnostic test | Healthy controls, Kawasaki disease |
Primary outcome
S100A12
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months
S100A12 was increased in children with Kawasaki disease and decreased after gamma globulin treatment
1 secondary outcome
CRP
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qihong Fan, Dr. principal investigator
Yangtze University
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnoses Disease, run by The First Affiliated Hospital of Yangtze University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Pan, Dr. (08618163139706, woshipanyan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S100A12 (time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.