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Assessment of Disease Activity in Behcet by Complete Blood Count

Primary Purpose

Behcet Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood samples
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Behcet Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • -Patient diagnosed as behcet disease by a rheumatologist
  • Age from 18 to 70 years old

Exclusion Criteria:

  • - Skin diseases,
  • Autoimmune diseases,
  • Inflammatory or infectious diseases,
  • Allergy,
  • Subjects with chronic diseases such as cardiovascular disorders, diabetes mellitus, or hematological, kidney, or liver diseases, hypertension, or malignant diseases
  • unwilling to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    complete blood count

    erythrocyte sedimentation rate

    Arm Description

    blood samples will be taken from patient and complete blood count is done early morning

    blood samples will be taken from patient and erythrocyte sedimentation rate is done

    Outcomes

    Primary Outcome Measures

    serum (PLR), (LMR), (MPV) and (NLR) in behcet disease and their correlation with disease activity.
    To determine platelet to lymphocyte ratio (PLR), lymphocytes to monocytes ratio (LMR), mean platelet volume (MPV) and neutrophile lymphocyte ratio (NLR), levels in Behçet's disease (BD) To investigate their correlation with disease activity

    Secondary Outcome Measures

    Full Information

    First Posted
    November 11, 2018
    Last Updated
    November 17, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03747354
    Brief Title
    Assessment of Disease Activity in Behcet by Complete Blood Count
    Official Title
    Serum (PLR), (LMR), (MPV) and (NLR) in Behcet Disease and Their Correlation With Disease Activity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2018 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    October 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To determine platelet to lymphocyte ratio (PLR), lymphocytes to monocytes ratio (LMR), mean platelet volume (MPV) and neutrophile lymphocyte ratio (NLR), levels in Behçet's disease (BD) To investigate their correlation with disease activity.
    Detailed Description
    Behçet' s disease (BD) is a complex, inflammatory multisystem disorder characterized by recurrent attacks of oral ulcers, genital ulcers, cutaneous lesions, and inflammatory ocular finding. The vascular inflammatory change is known to be the main histopathology. There is no sensitive or specific laboratory test or pathologic findings , the diagnosis relies heavily on mucocutaneous manifestations and other clinical findings. In the previous studies,In order to diagnose and monitor disease activity in BD, many cytokines and biomarkers have been identified such as increased blood levels of neopterin, a1-antitrypsin, a2- macroglobulin were correlated with disease activity. Some markers including interleukin-6, -interleukin1b, tumor necrosis factor a (TNF-a), thrombomodulin, E-selectin, vascular endothelial growth factor, antilysozyme(5), serum endocan, serum growth differentiation factor (GDF-15), serum alpha 1-acid glycoprotein, and homocysteine had been considered as inflammatory indicators in BD, However, they are not routinely used in clinical practice as they are not simple or easily derived. Limitations of these markers also include the reflection of short-term inflammatory activity and low discrimination ability with other superimposed inflammatory conditions. Currently, the platelet to lymphocyte ratio (PLR), lymphocyte to monocyte ratio (LMR), and similar parameters (red blood cell distribution width (RDW), mean platelet volume (MPV) and neutrophil to lymphocyte ratio (NLR), which can be calculated from the peripheral blood easily, have been demonstrated as a new expression of the systemic inflammatory indicators that can aid in the diagnosis and assessment of disease severity in many diseases, such as ankylosing spondylitis,rheumatoid arthritis,systemic lupus erythematosus,and psoriatic Arthritis.nevertheless, only a few studies have investigated RDW, NLR, PLR, or MPV values in patients with BD, none of which have evaluated the role of LMR in BD, not even the relationships between LMR, PLR levels, and disease activity in patients with BD. The mean size of the thrombocytes have been reported on the blood count as mean platelet volume (MPV). MPV is indirectly associated with the activity of platelets. Large platelets are more active than small ones by means of metabolic and enzymatic function. In addition, they also have a higher potential of thrombogenicity. LMR is an easy-to-calculate indicator that can be calculated by leukocyte subgroup of complete blood count. Also, it has been reported that LMR ratio might have prognostic importance for some diseases. Therefore, to better understand these serum inflammatory parameters in BD and to gain deeper insight into the roles of LMR, MPV, NLR and PLR in BD, a prospective study to assess them all together in BD Will conducted

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Behcet Syndrome

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    complete blood count
    Arm Type
    Active Comparator
    Arm Description
    blood samples will be taken from patient and complete blood count is done early morning
    Arm Title
    erythrocyte sedimentation rate
    Arm Type
    Active Comparator
    Arm Description
    blood samples will be taken from patient and erythrocyte sedimentation rate is done
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    blood samples
    Intervention Description
    blood samples
    Primary Outcome Measure Information:
    Title
    serum (PLR), (LMR), (MPV) and (NLR) in behcet disease and their correlation with disease activity.
    Description
    To determine platelet to lymphocyte ratio (PLR), lymphocytes to monocytes ratio (LMR), mean platelet volume (MPV) and neutrophile lymphocyte ratio (NLR), levels in Behçet's disease (BD) To investigate their correlation with disease activity
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: -Patient diagnosed as behcet disease by a rheumatologist Age from 18 to 70 years old Exclusion Criteria: - Skin diseases, Autoimmune diseases, Inflammatory or infectious diseases, Allergy, Subjects with chronic diseases such as cardiovascular disorders, diabetes mellitus, or hematological, kidney, or liver diseases, hypertension, or malignant diseases unwilling to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    esraa omar, master
    Phone
    01142171590
    Email
    drmtahtawy2017@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Naema Mohamed mostafa, professor
    Phone
    01223947372
    Email
    naimaaly@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    esraa omar, master
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28538403
    Citation
    Jiang Y, Zang M, Li S. Serum PLR and LMR in Behcet's disease: Can they show the disease activity? Medicine (Baltimore). 2017 May;96(21):e6981. doi: 10.1097/MD.0000000000006981.
    Results Reference
    background

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    Assessment of Disease Activity in Behcet by Complete Blood Count

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