Mast Cell Activation Test in Allergic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03406325
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : July 10, 2018
Chinese University of Hong Kong
Stanford University
Information provided by (Responsible Party):
Lee Tak Hong, Hong Kong Sanatorium & Hospital

Brief 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.

Condition or disease
Asthma Mastocytosis Mast Cell Activation Syndrome Food Allergy Chronic Idiopathic Urticaria Anaphylaxis Eczema

Detailed Description:

The objective of this study is to assess whether patients with severe allergic diseases exhibit high levels of mast cell activation as determined by the mast cell activation diagnostic test the investigators have developed. They anticipate that patients with history of severe allergic reactions will show up as high responders in the blood-based mast cell activation diagnostic test. Moreover, using microarray analysis as the approach for gene expression studies, they anticipate further that genomics biomarkers that are correlated with the high functional activation of the in-vitro mast cells derived from these patients can be readily identified.

About 100 ml of peripheral venous blood from individual patients will be drawn into heparinized syringes and collected in a blood-collecting bag/tube containing silica. The bag/tube will be promptly processed for the generation of primary human mast cell cultures using the protocol that has previously been developed [Inflammation Research 66: 25 (2017). After culturing for 9 weeks, the resulting human mast cells will be analyzed for both their functional activity in terms of histamine release in response to the activation of high-affinity IgE receptors in these cells and their gene expression profiles using microarray analysis. The in-vitro functional and genomics data will be correlated with specific diagnoses and measurements of blood prostaglandin D2 (PGD2), PGD2 metabolites, tryptase and histamine levels in blood. For mediator assays, plasma from each subject will be collected after the cluster of differentiation 34 positive (CD34+) isolation step and the samples will be aliquoted and frozen at -80 degrees centigrade for subsequent analysis.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of Mast Cell Activation Diagnostic Test in Patients With Allergic Disease
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Patients with this condition
Patients with this condition
Patients with this condition
food allergy
Patients with this condition
Patients with this condition
Patients with this condition
mast cell activating syndrome
Patients with this condition

Primary Outcome Measures :
  1. Correlation of genomic analyses with mediator release and specific diagnosis [ Time Frame: 18 months ]
    Mast cells will be cultured from peripheral venous blood and analysed for in vitro histamine release and gene expression profiles using microassay techniques. The results will be correlated with specific diagnoses and measurements of plasma histamine, PGD2 metabolites and tryptase.

Biospecimen Retention:   Samples Without DNA
blood samples for mediator measurements

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Highly allergic individuals

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03406325

Contact: WingPan Luk 28358426
Contact: Tak H Lee, MD SCD FRCP 28358430

Hong Kong
Hong Kong Sanatorium & Hospital Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
Hong Kong Sanatorium & Hospital
Chinese University of Hong Kong
Stanford University
Principal Investigator: Tak H Lee Hong Kong Sanatorium and Hospital

Responsible Party: Lee Tak Hong, Director Allergy Centre, Hong Kong Sanatorium & Hospital Identifier: NCT03406325     History of Changes
Other Study ID Numbers: REC-2017-17
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lee Tak Hong, Hong Kong Sanatorium & Hospital:
mast cell

Additional relevant MeSH terms:
Food Hypersensitivity
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type