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
About this trial
This is an interventional diagnostic trial for Behcet Syndrome
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
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
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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