N/A
N=19
Mast Cell Activation Test in Allergic Disease
Asthma · Mastocytosis · Mast Cell Activation Syndrome · Food Allergy · Chronic Idiopathic Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT03406325 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Mast Cell Activation Test Results for Validation Group — 6; 2; 0; 4 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hong Kong Sanatorium & Hospital
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mast Cell Activation Test Results for Validation Group |
6; 2; 0; 4 | — |
| PRIMARY Evaluation of Patient's Serum for Autoreactivity on Normal Average Responder Mast Cell Activation |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Percentage Histamine Release by Normal Average Responder Mast Cells + Patient's Serum to Assess Autoreactivity |
2.15; 32.1; 3.3; 2.8; 3.4; 5.1 | — |
| PRIMARY Percentage Histamine Release by Patient's Mast Cells + Immunoglobulin E (IgE)/Anti-IgE |
11.5; 38.3; 69.6; 47.9; 36.3; 45.5 | — |
| PRIMARY Percentage of Histamine Release by Patient's Mast Cells + Patient's Serum + Allergen |
24.5; 54.7; 79; 8.4; 0.2; 0.2 | — |
| PRIMARY Cell Yield Per 100ml Blood |
14045000; 2895522; 115294; 625263; 4867778; 352000 | — |
Summary
Activation of mast cells in the immune system is known to cause allergic reactions sometimes with severe systemic symptoms. The investigators have recently developed a blood-based mast cell activation diagnostic test in which levels of functional activation in-vitro in primary cultured mast cells generated from the peripheral blood of single individuals can be assessed. It is the hypothesis that the test can be used to predict the potential state of in-vivo mast cell activation in any individual based on the functional activation profiles exhibited by their cultured mast cells. The investigators now wish to translate their in-vitro findings in a pilot study to disease groups where mast cell activation is expected to be high. These include highly allergic individuals; those with chronic idiopathic urticaria; those with mastocytosis; and those with the mast cell activation syndrome. Furthermore, they will use the functional genomics approach to identify gene expression biomarkers that are correlated with such diseases. The results will be compared with data that have been collected from a cohort of healthy control blood donors.
Eligibility Criteria
Inclusion Criteria
Any patients with the above diagnoses -
Exclusion Criteria
Children < 18 years old; those who are unwilling or unable to donate blood; pregnant mothers.
-
Data sourced from ClinicalTrials.gov (NCT03406325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.