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Completed

NCT Number: NCT02671006

Monitoring Chronic Urticaria Basophil Irritability by Cytometry

A biological tool for quantitative assessment of Chronic Urticaria (CU) is still in need for monitoring biotherapies. CU is considered as a sudden degranulation of Mast cells / basophils without any identified cause. It is considered that Mast cell/basophil have an abnormally high sensitivity in CU and can be triggered with almost nothing (high irritability). In allergy, basophils degranulation can be reproduced in vitro with allergens. Anti-IgE (immunoglobulin E) antibody mimics allergen triggering of basophils in a dose dependent manner. If basophils are abnormally sensitive in CU, it should be reproduced in vitro at very low stimulation. The main objective of this project is to set up a method to evidence abnormal basophil irritability and look for clinical significance. As many markers characterize basophils in different states, researchers shall also look for a profile possibly associated with CU basophile irritability. Such tests could be useful in CU monitoring.

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Key information

Conditions

Urticaria Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint Etienne

Saint-Etienne, 42100, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Basophil patterns

Other

The Basophil patterns (CUBIC) will be compared between patients with urticaria and controls without Chronic Urticaria.

Other names: CUBIC

Primary outcomes

  1. Critical dose of anti IgE triggering half of basophils

    Time frame: Day 1

    Validate a new biological test measuring basophil "touchiness" in CU patients as potential diagnosis and gravity tool.

Secondary outcomes

  1. Antigen Density

    Time frame: Day 1

    Quantitative measurement of Antigen Density (phenotype, receptor density) will be performed to find a correlation with the severity of the disease.

  2. Urticaria Control Tests (UCT)

    Time frame: Day 1

    Urticaria Control Tests will be performed to measure the severity of the disease. It is composed of questions about the patients' symptoms.

  3. Urticaria Activity Score 7 (UAS7)

    Time frame: Day 1

    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.

  4. Optical Coherence Tomography (OCT)

    Time frame: Day 1

    Optical Coherence Tomography will be performed to examine the wheals. It is an in vivo microscopic technique.

  5. D Dimers dosage

    Time frame: Day 1

    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.

  6. IL33 dosage

    Time frame: Day 1

    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.

  7. Tryptase

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Novartis

Registry information

Official study title

Monitoring Chronic Urticaria Basophil Irritability by Cytometry (Monocentric Study)

Acronym: CUBIC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2016
Registry last updated
Sep 14, 2017

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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