Plasma Soluble Urokinase Plasminogen Activator Receptor and Behçet's Disease .

Behçet Disease Clinical Trial

Official title:

Relation Between Plasma Soluble Urokinase Plasminogen Activator Receptor and Behçet's Disease .

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04105439
• Other study ID #: suPAR in behcet disease
• Status: Not yet recruiting
• Start date: July 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: Mohamed Farghaly Ramadan, MD
• Phone: 01120782662
• Email: el.5abiry[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to determine whether plasma levels of the soluble urokinase plasminogen activator(suPAR) can serve as a blood-based biomarker for diagnosis of Behçet's disease and its correlation with disease activity.

Description:

Behçet's disease (BD) is a chronic, systemic vasculitis disease that can be evident in many systems and characterized by recurrent attacks, oral and/or genital aphthous ulcers, skin lesions, and inflammatory ocular findings. It was first described in 1937 by the Turkish dermatologist Hulusi Behçet.[1-3]

Although with an unclear pathogenesis, BD is considered a type of vasculitis triggered by immunological mechanisms. Increased levels of pro-inflammatory cytokines are reported in patients with BD. In the afflicted organs, a remarkable infiltration of neutrophils and lymphocytes can be seen.[4-6]

Diagnosis of BD is mainly clinical, on the association of symptoms, but diagnosis/classification criteria may help. Various sets of criteria were created for BD diagnosis and the recent one is the international criteria for Behçet's disease (ICBD) that was created by 27 countries in 2006 and revised in2014.[7]

There is no standard laboratory marker for the diagnosis and follow-up of BD. certain cytokines and increased serum levels of C-reactive protein (CRP) are considered as markers of disease activity.[8] Soluble urokinase plasminogen activator receptor (suPAR), a potential new biomarker, is a soluble form of the membrane-bound receptors expressed from and comprising mainly of various immune cells (monocytes, neutrophils, activated T lymphocytes, macrophages, endothelial cells, keratinocytes, smooth muscle cells and even tumor cells. [9] Numerous studies on various inflammatory diseases, cancer, tuberculosis, central nervous system infections, sepsis, liver fibrosis and inflammatory bowel disease have shown increased systemic levels of suPAR. In these diseases, suPAR systemic levels are shown to have a prognostic value in determining disease severity.[10]

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age = 18

• Patients diagnosed as Behçet's disease according to international study group criteria (ICBD ) for diagnosis of Behçet's

Exclusion Criteria:

• Age< 18 years

• Other autoimmune diseases.

• Pregnancy.

• Acute and chronic systemic infection history.

• The presence of chronic diseases such as chronic renal failure, liver and cardiac failure.

• Presence or history of cancer.

Related Conditions & MeSH terms

• Behçet Disease
• Behcet Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Adam B, Calikoglu E. Serum interleukin-6, procalcitonin and C-reactive protein levels in subjects with active Behçet's disease. J Eur Acad Dermatol Venereol. 2004 May;18(3):318-20. — View Citation

Criteria for diagnosis of Behçet's disease. International Study Group for Behçet's Disease. Lancet. 1990 May 5;335(8697):1078-80. Review. — View Citation

Gustafsson A, Ljunggren L, Bodelsson M, Berkestedt I. The Prognostic Value of suPAR Compared to Other Inflammatory Markers in Patients with Severe Sepsis. Biomark Insights. 2012;7:39-44. doi: 10.4137/BMI.S9460. Epub 2012 Apr 10. — View Citation

International Team for the Revision of the International Criteria for Behçet's Disease (ITR-ICBD). The International Criteria for Behçet's Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):338-47. doi: 10.1111/jdv.12107. Epub 2013 Feb 26. — View Citation

Koç Y, Güllü I, Akpek G, Akpolat T, Kansu E, Kiraz S, Batman F, Kansu T, Balkanci F, Akkaya S, et al. Vascular involvement in Behçet's disease. J Rheumatol. 1992 Mar;19(3):402-10. — View Citation

Köse O. Development of Immunopathogenesis Strategies to Treat Behçet's Disease. Patholog Res Int. 2012;2012:261989. doi: 10.1155/2012/261989. Epub 2012 Apr 3. — View Citation

Thunø M, Macho B, Eugen-Olsen J. suPAR: the molecular crystal ball. Dis Markers. 2009;27(3):157-72. doi: 10.3233/DMA-2009-0657. Review. — View Citation

Türsen U. Pathophysiology of the Behçet's Disease. Patholog Res Int. 2012;2012:493015. doi: 10.1155/2012/493015. Epub 2011 Oct 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of the level of suPAR in the study subjects.	to study the relation between leve of the marker and presence of the diesase.	baseline
Secondary	evaluation of the levels of suPAR with the activity of the disease.	to study relation between level of the marker and activity of the disease	baseline

External Links

•   University of Leeds. Behçet's Disease Current Activity Form 2006. available at the site.