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Monitoring Chronic Urticaria Basophil Irritability by Cytometry (CUBIC)

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ClinicalTrials.gov Identifier: NCT02671006
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date January 25, 2016
First Posted Date February 2, 2016
Last Update Posted Date September 14, 2017
Actual Study Start Date March 2016
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 28, 2016)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 31, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Monitoring Chronic Urticaria Basophil Irritability by Cytometry
Official Title Monitoring Chronic Urticaria Basophil Irritability by Cytometry (Monocentric Study)
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood sample will be collected during a venipuncture required for the medical follow up and should not interfere with the usual treatment.
Sampling Method Probability Sample
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.
Condition Urticaria
Intervention Other: Basophil patterns
The Basophil patterns (CUBIC) will be compared between patients with urticaria and controls without Chronic Urticaria.
Other Name: CUBIC
Study Groups/Cohorts
  • 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.
    Intervention: Other: Basophil patterns
  • 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.
    Intervention: Other: Basophil patterns
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 28, 2016)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date August 31, 2017
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02671006
Other Study ID Numbers 1508109
2015-A01347-42 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators Novartis
Investigators
Principal Investigator: LAMBERT Claude, MD CHU SAINT ETIENNE
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date December 2016