The Role of Biomarkers in the Occurrence and Development of Asthma
1 other identifier
observational
2
1 country
1
Brief Summary
To study the expression level of biomarkers such as GITRL in peripheral blood of children with asthma and analyze their correlation with the severity of asthma. To study the predictive value of biomarkers level for the occurrence and development of asthma. And to provide supplementary detection means and predictive indicators for the diagnosis of asthma and the severity of asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 14, 2023
CompletedStudy Start
First participant enrolled
July 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
July 7, 2023
July 1, 2023
5.5 years
February 7, 2023
July 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The level of biomarkers
All participants will be extracted 5ml peripheral blood into the anticoagulant tube by nurses and the peripheral blood will be detected for biomarkers of asthma using RT-qPCR、 ELISA、 Flow cytometry and other methods.
2years
Secondary Outcomes (7)
Pulmonary function（FEV1%）
2 years
Pulmonary function（FVC%）
2 years
Pulmonary function（FEV1/FVC）
2 years
Pulmonary function（PEF%）
2 years
specific IgE
2 years
- +2 more secondary outcomes
Study Arms (2)
Asthma group
Children with asthma diagnosed by a respiratory physician
Control group
Children without respiratory disease or inflammatory diseases
Interventions
All participants will be extracted 5ml peripheral blood into the anticoagulant tube by nurses and the peripheral blood will be detected for biomarkers of asthma. Children with asthma will take pulmonary function, blood test and specific IgE test etc. The lung function test will be performed by professional technicians and the results will be interpreted by specialists. The blood test and specific IgE test will be collected by specialist nurses and the results will be issued by professional inspectors. Children with asthma and their guardians will be asked for filling the questionnaire of Childhood Asthma Control Test (C-ACT). And then the doctor will check and calculate the scores after completion.
Eligibility Criteria
Children with typical asthma symptoms, such as cough, wheezing, chest tightness, dyspnea and abnormal lung function tests, were diagnosed with asthma by a respiratory doctor
You may qualify if:
- In line with the diagnostic criteria in the Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children (2016 Edition)
- Age: 4-12 years old for new diagnosis or recurrent episodes
- Typical clinical manifestations and complete clinical data
- Family members or guardians of children with informed research and signed consent
- All healthy control subjects had no history of lung disease, allergic rhinitis or any other atopic disease
You may not qualify if:
- Suffering from other respiratory diseases (such as bronchiectasis, allergic rhinitis, respiratory failure, tuberculosis, obstructive airway disease) or other inflammatory diseases.
- Abnormal development of congenital airway and lung tissue
- History of immunosuppressant or glucocorticoid use in the first 4 weeks
- Suffering from other endocrine system and immune system diseases
- Incomplete clinical data or examinations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shaoqing Zhang
Chongqing, Chongqing Municipality, 400000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Reseacher
Study Record Dates
First Submitted
February 7, 2023
First Posted
March 14, 2023
Study Start
July 4, 2023
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
July 7, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share