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NCT Number: NCT03406325

Mast Cell Activation Test in Allergic Disease

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.

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Key information

Conditions

Asthma Anaphylaxis Bronchial Diseases Chronic Disease Chronic Idiopathic Urticaria Chronic Urticaria Dermatitis Disease Attributes Eczema Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Mast Cell Activation Disorders Mast Cell Activation Syndrome Mastocytosis Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hong Kong Sanatorium & Hospital

Hong Kong

About this study

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 Immunoglobulin E (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Primary outcomes

  1. Mast Cell Activation Test Results for Validation Group

    Time frame: Mast cells studied after 9 weeks in culture

    Mast Cell Activation Test results of high/low level of house dust mite sensitivity by using normal donor cultured mast cells for validation.

  2. Evaluation of Patient's Serum for Autoreactivity on Normal Average Responder Mast Cell Activation

    Time frame: Mast cells studied after 9 weeks in culture

    Patient's serum was incubated with mast cells derived from normal donors for detection of mast cell activation as evidenced by histamine release.

  3. Percentage Histamine Release by Normal Average Responder Mast Cells + Patient's Serum to Assess Autoreactivity

    Time frame: Mast cells studied after 9 weeks in culture

    percentage of total histamine release by normal average responder mast cells that had been activated with patient's serum

  4. Percentage Histamine Release by Patient's Mast Cells + Immunoglobulin E (IgE)/Anti-IgE

    Time frame: Mast cells studied after 9 weeks in culture

    percentage of total histamine release by patient's mast cells that had been activated with anti-IgE

  5. Percentage of Histamine Release by Patient's Mast Cells + Patient's Serum + Allergen

    Time frame: Mast cells studied after 9 weeks in culture

    Percentage of total histamine release when patient's mast cells were activated with patient's own serum and Der p2. Each patient's results are reported individually.

  6. Cell Yield Per 100ml Blood

    Time frame: Mast cells studied after 9 weeks in culture

    Cell yield of patient's mast cell culture after 9 weeks in culture as an index of cell growth and differentiation.

Sponsors and collaborators

Lead sponsor

Hong Kong Sanatorium & Hospital

Industry

Collaborators

  • Chinese University of Hong Kong
  • Stanford University

Registry information

Official study title

Assessment of Mast Cell Activation Diagnostic Test in Patients With Allergic Disease

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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