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Establishment of a Serum-Induced Mast Cell Activation Assay and Its Application in the Evaluation of Allergic Reactions

Establishment of a Serum-Induced Mast Cell Activation Assay and Its Application in the Evaluation of Allergic Reactions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113949
Enrollment
Unknown
Registered
2025-12-04
Start date
2024-07-16
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal allergic rhinitis

Interventions

Gold Standard:specific IgE test,total IgE test
Index test:The diagnostic test under evaluation in this study is the Serum-Stimulated Mast Cell Activation Test. This method simulates the effect of allergens on mast cells in vivo to directly observe

Sponsors

Yulin Hospital, The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Case group: (1) Males or females aged 18 to 65 years old; (2) Presenting with typical symptoms clearly attributable to allergies, and the clinical doctor's comprehensive judgment confirms that the symptoms are consistent with the characteristics of an allergic reaction; (3) There is a temporal association between the onset of symptoms and exposure to suspected allergens, with symptoms appearing within a certain period after exposure; (4) Allergen test results meet the following criteria: 1) Weed pollen serum sIgE >= grade II or skin test >= "++"; 2) Dust mite, mold and pet serum sIgE test result 0 grade or skin test result "-". 2.Control group: (1) Males or females aged 18 to 65 years old; (2) Individuals without the above symptoms of allergic rhinitis.

Exclusion criteria

Exclusion criteria: 1. Patients with malignant tumors; 2. Pregnant or breastfeeding individuals; 3. Individuals with other severe liver, kidney, heart, hematopoietic, neurological, or psychiatric diseases; 4. Other situations deemed unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
CD63;

Secondary

MeasureTime frame
Histamine;

Countries

China

Contacts

Public ContactWendong Hao

Yulin Hospital, The First Affiliated Hospital of Xi'an Jiaotong University

hwdokgood@hotmail.com+86 187 0011 3089

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026