- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02671006
Monitoring Chronic Urticaria Basophil Irritability by Cytometry (CUBIC)
Monitoring Chronic Urticaria Basophil Irritability by Cytometry (Monocentric Study)
Study Overview
Detailed Description
Mast cell is a key factor in Urticaria physiopathology. Several mechanisms have been hypothesized and could be either synergistic or revealing different types of urticaria. But most of these mechanisms seem to converge to Mast cells releasing histamine and other products. These mechanisms include auto-antibody and / or cytokines inappropriate production. However, internal dysregulation of Mast cell have also been reported, that could be either primary or secondary to extrinsic mediators mentioned already. Basophils closely related to Mast cells, easily accessible and usually serve as surrogate for clinical analysis of allergy or urticaria.
Flow-cytometry (FCM) is a recent tool with increasing interest due to its exceptional capacity of analysis of a large number of cells, individually, at high speed and measuring many parameters at a time. FCM has been extensively used in characterization of cell sub populations in several diseases such as hematology disorders or immunology and among them the basophil. FCM is now the gold standard for ex vivo functional analyses of basophil activation as part of the diagnosis of allergy.
The present project aims to explore phenotypic and functional changes that could reflect the dysregulation in Urticaria. This would have diagnosis and physiopathological interest with potential impact on optimizing disease monitoring and treatment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Saint Etienne, France, 42100
- CHU Saint Etienne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patient analysis will be performed on
- 30 patients with an active CU according to the EAACI criteria.
- 30 volunteers with no history of immediate allergy (patients under medical follow up for melanoma in remission for at least 3 months, age (+/- 5 years) and sex matched). Controls should have no history of atopy, urticaria or immediate allergy declared (rhinitis, urticaria, asthma) at the time of the test. Blood sample will be collected during a venipuncture required for the medical follow up and should not interfere with the usual treatment.
Description
Inclusion Criteria:
- Patients :
- Active Chronic Urticaria according to the EAACI 2014 criteria.
- Healthy volunteers :
- Age (approx. +/- 5 years matched with patient group),
- Sexe matched.
Exclusion Criteria:
- Patients
- Treated by Omalizumab
- Healthy volunteers :
- Allergy,
- Atopy,
- Urticaria.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Patients with an active Chronic Urticaria according to the EAACI criteria will be included.
The Basophil patterns (CUBIC) will be compared between patients with urticaria and controls without Chronic Urticaria.
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The Basophil patterns (CUBIC) will be compared between patients with urticaria and controls without Chronic Urticaria.
Other Names:
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Volunteers
Volunteers must no have history of immediate allergy (patients under medical follow up for melanoma in remission for at least 3 months, age (+/- 5 years) and sex matched).
Controls should have no history of atopy, urticaria or immediate allergy declared (rhinitis, urticaria, asthma) at the time of the test.
The Basophil patterns (CUBIC) will be compared between patients with urticaria and controls without Chronic Urticaria.
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The Basophil patterns (CUBIC) will be compared between patients with urticaria and controls without Chronic Urticaria.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Critical dose of anti IgE triggering half of basophils
Time Frame: Day 1
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Validate a new biological test measuring basophil "touchiness" in CU patients as potential diagnosis and gravity tool.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antigen Density
Time Frame: Day 1
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Quantitative measurement of Antigen Density (phenotype, receptor density) will be performed to find a correlation with the severity of the disease.
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Day 1
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Urticaria Control Tests (UCT)
Time Frame: Day 1
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Urticaria Control Tests will be performed to measure the severity of the disease.
It is composed of questions about the patients' symptoms.
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Day 1
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Urticaria Activity Score 7 (UAS7)
Time Frame: Day 1
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Urticaria Activity Score 7 will be performed to measure the severity of the disease.
After 7 days, average daily scores from the morning and evening assessments are added together.
Values can range between 0 to 21 for weekly itch severity, and 0 to 21 for weekly hive count.
The UAS7 ranges from 0 to 42.
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Day 1
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Optical Coherence Tomography (OCT)
Time Frame: Day 1
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Optical Coherence Tomography will be performed to examine the wheals.
It is an in vivo microscopic technique.
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Day 1
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D Dimers dosage
Time Frame: Day 1
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Partial activation of some cells such as Eosinophils leads to exposure of tissue factors and low level activation of the coagulation.
D-dimers are produced and it was proposed that these d-dimers could be a trigger of basophils.
The dosage of the D Dimers will be performed to find a possible correlation with the severity of the disease.
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Day 1
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IL33 dosage
Time Frame: Day 1
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The level of circulating IL-33 (Interleukin 33) will be measured to find a correlation with the severity of the disease because in recent reports, IL-33 have been shown to increase Basophils reactivity and possibly play a role in urticaria.
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Day 1
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Tryptase
Time Frame: Day 1
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Tryptase (a stable Mast cell specific product) is increased in CU crisis, that is why the dosage of the tryptase will be performed to find out the correlation with the severity of the disease.
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Day 1
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: LAMBERT Claude, MD, CHU Saint Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1508109
- 2015-A01347-42 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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