Role of Endothelial Cells in the Pathogenesis of Chronic Urticaria.
NCT ID: NCT03443362
Last Updated: 2022-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
70 participants
OBSERVATIONAL
2018-02-01
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This research's main perspective is to improve quality of life for CU patients by first of all focusing on a good clinical diagnosis of (different subtypes of) CU in a CU reference center, and secondly by gaining more insight on the pathogenesis of the disease to expand knowledge on potential new targeted treatments for the patients.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients
NCT01803763
Monitoring Chronic Urticaria Basophil Irritability by Cytometry
NCT02671006
Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
NCT01723072
Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment
NCT01599637
Molecular Endotypes of Chronic Idiopathic Urticaria
NCT04774315
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
It is generally proposed that patients with CU have defects in mast cell and/or basophil trafficking, signaling and/or function. Nevertheless more recently also other cells seem to be involved: lymphocytes, eosinophils, endothelial cells (ECs). The integrity of EC structure and function is important in the maintenance of the vessel wall and circulatory function. As a barrier, the endothelium is semi-permeable and controls molecular transport between the blood and the tissues. Under basal conditions, ECs are involved in maintaining the anti-thrombotic blood-tissue interface by regulating thrombosis, thrombolysis, platelet adherence, vascular tone and blood flow. In CU, mast cells are activated and histamine release occurs. This histamine binds to its receptor on the ECs causing vasodilation and extravasation. This endothelial function/dysfunction can be characterized by several biological markers from different signalization/activation pathways. Vascular injury induces release of vascular endothelial growth factor (VEGF) to stimulate angiogenesis. Cytokine stimulation triggers the expression and release of adhesion molecules (e.g., E-selectin, ICAM-1, VCAM-1), making transendothelial migration of lymphocytes possible. In particular, E-selectin is expressed only by activated endothelium; however, its circulating form (sE-selectin) can be found in the plasma after enzymatic cleavage or from shedding by damaged or active ECs. Furthermore it is known for ECs to interact with mast cells through the production of Stem Cell Factor (SCF; c-kit ligand) to influence mast cell proliferation and differentiation. Asero et al (2003) determined serum SCF levels in 65 CIU patients and found no difference from those found in healthy controls. Nevertheless, the increase in mast cells in skin biopsy specimens, along with the absence of systemic eosinophilia in CIU patients suggests a possible role for stem cell factor (SCF) in CU pathogenesis.
Endothelial progenitor cells (EPC) normally have the ability to develop into fully mature EC and contribute to neovascularization by targeting sites of endothelial injury. Furthermore it is shown that acute exercise-induced nitric oxide production contributes to upregulation of circulating endothelial progenitor cells in healthy subjects. Since exercise is a known trigger for CU, it would be interesting to investigate the effect of exercise on EPC recruitment and EC activation in CSU.
Microvascular damage and EC injury is described in multiple diseases such as diabetes and scleroderma. This can be evaluated by nail fold videocapillaroscopy (NVC). The integrity of vessel walls is compromised in CU, of which the appearance of wheals due to the extravasation process seems to be the most obvious symptom clinically. It would be interesting to examine if there are microscopical abnormalities on NVC that could help identify (certain subtypes of) CU. If present, correlations between these abnormalities and disease severity can be further investigated.
The objectives of the study are:
* To determine the incidence of CU (CSU and CIU) in a Belgian city center hospital
* To investigate the role of ECs in CSU on a clinical and molecular level
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chronic urticaria
50 consecutive chronic urticaria patients receiving medical care within the CHU Brugmann Hospital. Diagnose according to the European Academy of Allergy and Clinical Immunology (EAACI) guidelines.
Punch Biopsy
A 3 mm punch biopsy will be taken from lesional and non-lesional skin as a routine procedure.
Blood sampling
Blood sampling
Control
20 healthy control patients, without chronic urticaria. Patients coming to the CHU Brugmann hospital for the excision of atypical naevi.
Punch Biopsy
A 3 mm punch biopsy will be taken from lesional and non-lesional skin as a routine procedure.
Blood sampling
Blood sampling
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Punch Biopsy
A 3 mm punch biopsy will be taken from lesional and non-lesional skin as a routine procedure.
Blood sampling
Blood sampling
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Olivier Michel
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Olivier Michel
Head of clinic
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yora Mostmans, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Brugmann
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Brugmann
Brussels, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yora Mostmans, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Kaplan AP. Chronic urticaria: pathogenesis and treatment. J Allergy Clin Immunol. 2004 Sep;114(3):465-74; quiz 475. doi: 10.1016/j.jaci.2004.02.049.
Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, Church MK, Ensina LF, Gimenez-Arnau A, Godse K, Goncalo M, Grattan C, Hebert J, Hide M, Kaplan A, Kapp A, Abdul Latiff AH, Mathelier-Fusade P, Metz M, Saini SS, Sanchez-Borges M, Schmid-Grendelmeier P, Simons FE, Staubach P, Sussman G, Toubi E, Vena GA, Wedi B, Zhu XJ, Nast A, Maurer M; Dermatology Section of the European Academy of Allergy and Clinical Immunology; Golbal Allergy and Asthma European Network; European Dermatology Forum; World Allergy Organization. Methods report on the development of the 2013 revision and update of the EAACI/GA2 LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2014 Jul;69(7):e1-29. doi: 10.1111/all.12370.
Greaves M. Chronic urticaria. J Allergy Clin Immunol. 2000 Apr;105(4):664-72. doi: 10.1067/mai.2000.105706.
Gaig P, Olona M, Munoz Lejarazu D, Caballero MT, Dominguez FJ, Echechipia S, Garcia Abujeta JL, Gonzalo MA, Lleonart R, Martinez Cocera C, Rodriguez A, Ferrer M. Epidemiology of urticaria in Spain. J Investig Allergol Clin Immunol. 2004;14(3):214-20.
Hellgren L. The prevalence of urticaria in the total population. Acta Allergol. 1972;27(3):236-40. doi: 10.1111/j.1398-9995.1972.tb01420.x. No abstract available.
Zuberbier T, Balke M, Worm M, Edenharter G, Maurer M. Epidemiology of urticaria: a representative cross-sectional population survey. Clin Exp Dermatol. 2010 Dec;35(8):869-73. doi: 10.1111/j.1365-2230.2010.03840.x.
Sumpio BE, Riley JT, Dardik A. Cells in focus: endothelial cell. Int J Biochem Cell Biol. 2002 Dec;34(12):1508-12. doi: 10.1016/s1357-2725(02)00075-4.
Constans J, Conri C. Circulating markers of endothelial function in cardiovascular disease. Clin Chim Acta. 2006 Jun;368(1-2):33-47. doi: 10.1016/j.cca.2005.12.030. Epub 2006 Mar 10.
Coleman JW, Holliday MR, Kimber I, Zsebo KM, Galli SJ. Regulation of mouse peritoneal mast cell secretory function by stem cell factor, IL-3 or IL-4. J Immunol. 1993 Jan 15;150(2):556-62.
Asero R, Tedeschi A, Lorini M, Gerosa M, Meroni P, Riboldi P. Circulating stem cell factor in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2003 Jul;91(1):79-81. doi: 10.1016/S1081-1206(10)62063-7.
Kuwana M, Okazaki Y. Quantification of circulating endothelial progenitor cells in systemic sclerosis: a direct comparison of protocols. Ann Rheum Dis. 2012 Apr;71(4):617-20. doi: 10.1136/annrheumdis-2011-200713. Epub 2012 Jan 17.
Yang Z, Wang JM, Chen L, Luo CF, Tang AL, Tao J. Acute exercise-induced nitric oxide production contributes to upregulation of circulating endothelial progenitor cells in healthy subjects. J Hum Hypertens. 2007 Jun;21(6):452-60. doi: 10.1038/sj.jhh.1002171. Epub 2007 Mar 15.
Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. doi: 10.1161/hc3901.095960. No abstract available.
Cutolo M, Sulli A, Pizzorni C, Smith V. Capillaroscopy as an Outcome Measure for Clinical Trials on the Peripheral Vasculopathy in SSc-Is It Useful? Int J Rheumatol. 2010;2010:784947. doi: 10.1155/2010/784947. Epub 2010 Aug 16.
Mostmans Y, De Smedt K, Feoli F, Waelput W, De Maertelaer V, Olemans C, Meiers I, Cielen T, Corazza F, Michel O, Richert B. Elevated cutaneous expression of stem cell factor in chronic spontaneous urticaria: a prospective cohort study. Clin Exp Dermatol. 2024 Nov 22;49(12):1659-1667. doi: 10.1093/ced/llae252.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUB-Chronic urticaria
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.