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

NCT ID: NCT04105439

Last Updated: 2021-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-12-01

Brief Summary

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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.

Detailed Description

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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.\[10\]

Conditions

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Behçet Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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control

healthy subjects who do not have the disease

No interventions assigned to this group

patients with Behçet's disease

subjects who do have the disease ( Behçet's disease )

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Farghaly Ramadan

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohamed Farghaly Ramadan, MD

Role: CONTACT

01120782662

References

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

Reference Type BACKGROUND
PMID: 1970380 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 1578454 (View on PubMed)

Kose O. Development of Immunopathogenesis Strategies to Treat Behcet's Disease. Patholog Res Int. 2012;2012:261989. doi: 10.1155/2012/261989. Epub 2012 Apr 3.

Reference Type BACKGROUND
PMID: 22550612 (View on PubMed)

Tursen U. Pathophysiology of the Behcet's Disease. Patholog Res Int. 2012;2012:493015. doi: 10.1155/2012/493015. Epub 2011 Oct 1.

Reference Type BACKGROUND
PMID: 21977335 (View on PubMed)

International Team for the Revision of the International Criteria for Behcet's Disease (ITR-ICBD). The International Criteria for Behcet'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.

Reference Type BACKGROUND
PMID: 23441863 (View on PubMed)

Adam B, Calikoglu E. Serum interleukin-6, procalcitonin and C-reactive protein levels in subjects with active Behcet's disease. J Eur Acad Dermatol Venereol. 2004 May;18(3):318-20. doi: 10.1111/j.1468-3083.2004.00907.x.

Reference Type BACKGROUND
PMID: 15096143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22550400 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 19893210 (View on PubMed)

Other Identifiers

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suPAR in behcet disease

Identifier Type: -

Identifier Source: org_study_id

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