Mast Cell Activation Test in Allergic Disease

NCT03406325 | Completed Results

• 1 other identifier: REC-2017-17
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Mastocytosis; Mast Cell Activation Syndrome; Food Allergy; Chronic Idiopathic Urticaria; Anaphylaxis; Eczema

Keywords

mast cell; allergy; genomic; biomarkers

Outcome Measures

Primary Outcomes (6)

• Mast Cell Activation Test Results for Validation Group

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

  Mast cells studied after 9 weeks in culture

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

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

  Mast cells studied after 9 weeks in culture

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

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

  Mast cells studied after 9 weeks in culture

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

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

  Mast cells studied after 9 weeks in culture

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

  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.

  Mast cells studied after 9 weeks in culture

• Cell Yield Per 100ml Blood

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

  Mast cells studied after 9 weeks in culture

Study Arms (7)

urticaria

Patients with this condition

asthma

Patients with this condition

eczema

Patients with this condition

food allergy

Patients with this condition

anaphylaxis

Patients with this condition

mastocytosis

Patients with this condition

mast cell activating syndrome

Patients with this condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Highly allergic individuals

You may qualify if:

• Any patients with the above diagnoses -

You may not qualify if:

• Children \< 18 years old; those who are unwilling or unable to donate blood; pregnant mothers.

Sponsors & Collaborators

• Hong Kong Sanatorium & Hospital: lead
• Chinese University of Hong Kong: collaborator
• Stanford University: collaborator

Study Sites (1)

Hong Kong Sanatorium & Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• Tam IYS, Ng CW, Tam SY, Lau HYA. Novel six-week protocol for generating functional human connective tissue-type (MCTC) mast cells from buffy coats. Inflamm Res. 2017 Jan;66(1):25-37. doi: 10.1007/s00011-016-0989-z. Epub 2016 Sep 15.

  PMID: 27628164 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for mediator measurements

MeSH Terms

Conditions

Asthma; Mastocytosis; Mast Cell Activation Syndrome; Food Hypersensitivity; Chronic Urticaria; Anaphylaxis; Eczema; Hypersensitivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Prof. Tak Hong Lee
• Organization: Hong Kong Sanatorium & Hospital

TakHong.Lee@hksh.com

28358430

Study Officials

• Tak H Lee

  Hong Kong Sanatorium and Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Allergy Centre

Study Record Dates

• First Submitted: January 14, 2018
• First Posted: January 23, 2018
• Study Start: February 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 9, 2020
• Results First Posted: April 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)