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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04105439
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : March 27, 2020
Information provided by (Responsible Party):
Mohamed Farghaly Ramadan, Assiut University

Brief 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.

Condition or disease
Behçet Disease

Detailed 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]

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Relation Between Plasma Soluble Urokinase Plasminogen Activator Receptor and Behçet's Disease .
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : December 1, 2021

healthy subjects who do not have the disease
patients with Behçet's disease
subjects who do have the disease ( Behçet's disease )

Primary Outcome Measures :
  1. evaluation of the level of suPAR in the study subjects. [ Time Frame: baseline ]
    to study the relation between leve of the marker and presence of the diesase.

Secondary Outcome Measures :
  1. evaluation of the levels of suPAR with the activity of the disease. [ Time Frame: baseline ]
    to study relation between level of the marker and activity of the disease

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
adult patients age ≥ 18 years old and are diagnosed as Behçet's disease according to international study group criteria (ICBD ) for diagnosiss of Behçet's

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04105439

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Contact: Mohamed Farghaly Ramadan, MD 01120782662

Sponsors and Collaborators
Assiut University
Additional Information:

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Responsible Party: Mohamed Farghaly Ramadan, resident doctor, Assiut University Identifier: NCT04105439    
Other Study ID Numbers: suPAR in behcet disease
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular