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Status unknownNCT04105439Updated Jan 13, 2021

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

An observational study in Behçet Disease, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-13.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Behçet Disease

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03

In context

Behcet Syndrome

136 studies on the registry are indexed under Behcet Syndrome; 43 are open to participants now.

This study's planned enrollment of 90 is close to the median of 90 across 63 observational studies indexed under Behcet Syndrome.

Browse Behcet Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • control

    healthy subjects who do not have the disease

  • patients with Behçet's disease

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

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What researchers measure

Primary outcomes

  1. evaluation of the level of suPAR in the study subjects.

    to study the relation between leve of the marker and presence of the diesase.

    Time frame: baseline

Secondary outcomes

  1. 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

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Criteria for diagnosis of Behcet's disease. International Study Group for Behcet's Disease. Lancet. 1990 May 5;335(8697):1078-80. PubMed 1970380 ↗
  • 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. PubMed 1578454 ↗
  • 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. PubMed 22550612 ↗
  • Tursen U. Pathophysiology of the Behcet's Disease. Patholog Res Int. 2012;2012:493015. doi: 10.1155/2012/493015. Epub 2011 Oct 1. PubMed 21977335 ↗
  • 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. PubMed 23441863 ↗
  • 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. PubMed 15096143 ↗
  • 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. PubMed 22550400 ↗
  • 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. PubMed 19893210 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04105439
Lead sponsor
Assiut University
Responsible party
Mohamed Farghaly Ramadan (resident doctor, Assiut University) — Principal investigator
First posted
Sep 26, 2019
Start date
Jul 1, 2021 (estimated)
Primary completion
Nov 1, 2021 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
Jan 13, 2021

Study contacts

Mohamed Farghaly Ramadan, MD
Contact
el.5abiry@gmail.com
01120782662

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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