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Assessment of Disease Activity in Behcet by Complete Blood Count

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ClinicalTrials.gov Identifier: NCT03747354
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
esraa omar ali, Assiut University

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.

Condition or disease Intervention/treatment Phase
Behcet Syndrome Diagnostic Test: blood samples Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Serum (PLR), (LMR), (MPV) and (NLR) in Behcet Disease and Their Correlation With Disease Activity
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Active Comparator: complete blood count
blood samples will be taken from patient and complete blood count is done early morning
Diagnostic Test: blood samples
blood samples

Active Comparator: erythrocyte sedimentation rate
blood samples will be taken from patient and erythrocyte sedimentation rate is done
Diagnostic Test: blood samples
blood samples




Primary Outcome Measures :
  1. serum (PLR), (LMR), (MPV) and (NLR) in behcet disease and their correlation with disease activity. [ Time Frame: baseline ]
    • 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747354


Contacts
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Contact: esraa omar, master 01142171590 drmtahtawy2017@yahoo.com
Contact: Naema Mohamed mostafa, professor 01223947372 naimaaly@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: esraa omar, master Assiut University

Publications:
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Responsible Party: esraa omar ali, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03747354     History of Changes
Other Study ID Numbers: disease activity in behcet
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular