AsthmaNCT03406325
Mast Cell Activation Test in Allergic Disease
An observational study of Asthma and Mastocytosis, run by Hong Kong Sanatorium & Hospital at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Mastocytosis, Mast Cell Activation Syndrome
- How many people
- 19 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Highly allergic individuals
Who may be able to join
- Any patients with the above diagnoses -
Who cannot join
- Children < 18 years old; those who are unwilling or unable to donate blood; pregnant mothers.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Mast Cell Activation Diagnostic Test in Patients With 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.
Read the 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 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.
- Conditions
- Asthma, Mastocytosis, Mast Cell Activation Syndrome, Food Allergy, Chronic Idiopathic Urticaria, Anaphylaxis
- Keywords
- mast cell, allergy, genomic, biomarkers
- Medical subject headings
- Asthma, Mastocytosis, Mast Cell Activation Syndrome, Food Hypersensitivity, Chronic Urticaria, Anaphylaxis, Eczema, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Mast cells studied after 9 weeks in culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Feb 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Sanatorium & Hospital
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong, Stanford University
- Responsible party
- Principal investigator, Lee Tak Hong, Hong Kong Sanatorium & Hospital
- Investigators
- Tak H Lee, Principal investigator, Hong Kong Sanatorium and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406325
- Sponsor's protocol ID
- REC-2017-17
- Status last verified
- Mar 2020
- First submitted
- 14 Jan 2018
- Last updated
- 9 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27628164
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mast Cell Activation Diagnostic Test in Patients With Allergic Disease
- ClinicalTrials.gov ID
- NCT03406325
- Acronym / sponsor ID
- REC-2017-17
- Conditions
- Asthma, Mastocytosis, Mast Cell Activation Syndrome, Food Allergy, Chronic Idiopathic Urticaria, Anaphylaxis
- Keywords
- mast cell, allergy, genomic, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hong Kong Sanatorium & HospitalIndustry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong, Stanford University
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 9 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Highly allergic individuals
Key inclusion criteria (1 listed)
- Any patients with the above diagnoses -
Key exclusion criteria (2 listed)
- Children < 18 years old; those who are unwilling or unable to donate blood; pregnant mothers.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
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
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27628164Tam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tak H Lee principal investigator
Hong Kong Sanatorium and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Mastocytosis, run by Hong Kong Sanatorium & Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mast Cell Activation Test Results for Validation Group (time frame: Mast cells studied after 9 weeks in culture). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03406325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.