Clincosm LogoSign in Get a demo

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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04105439
Collaborator
(none)
90
Enrollment
5
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    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]

    Study Design

    Study Type:
    Observational
    Anticipated 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 .
    Anticipated Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    control

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

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

    Outcome Measures

    Primary Outcome Measures

    1. evaluation of the level of suPAR in the study subjects. [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. [baseline]

      to study relation between level of the marker and activity of the disease

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed Farghaly Ramadan, resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04105439
    Other Study ID Numbers:
    • suPAR in behcet disease
    First Posted:
    Sep 26, 2019
    Last Update Posted:
    Jan 13, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Behcet Syndrome

    Study Results

    No Results Posted as of Jan 13, 2021