Monitoring Chronic Urticaria Basophil Irritability by Cytometry

NCT ID: NCT02671006

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-08-31

Brief Summary

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.

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.

Conditions

Urticaria

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Basophil patterns

Intervention Type: OTHER

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

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.

Basophil patterns

Intervention Type: OTHER

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

Interventions

Basophil patterns

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

Intervention Type: OTHER

Other Intervention Names

CUBIC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LAMBERT Claude, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2015-A01347-42

Identifier Type: OTHER

Identifier Source: secondary_id

1508109

Identifier Type: -

Identifier Source: org_study_id