Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03747354
Other study ID # disease activity in behcet
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2018
Est. completion date October 2019

Study information

Verified date November 2018
Source Assiut University
Contact esraa omar, master
Phone 01142171590
Email drmtahtawy2017@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date October 2019
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
blood samples
blood samples

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Jiang Y, Zang M, Li S. Serum PLR and LMR in Behçet's disease: Can they show the disease activity? Medicine (Baltimore). 2017 May;96(21):e6981. doi: 10.1097/MD.0000000000006981. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
baseline
See also
  Status Clinical Trial Phase
Completed NCT03274648 - Dietary Interventions and Butyrate Production in Behçet's Patients N/A
Terminated NCT01693653 - Tocilizumab for the Treatment of Behcet's Syndrome Phase 2
Completed NCT04961463 - Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model N/A
Completed NCT05142995 - Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease
Recruiting NCT00931957 - Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease N/A
Completed NCT03514056 - Frequency of Fibromyalgia in Behcet Disease
Not yet recruiting NCT03771768 - Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease N/A
Terminated NCT03554161 - Tocilizumab for the Treatment of Refractory Behcet's Uveitis Phase 2
Recruiting NCT04738864 - Neuro-ultrasound Assessment in Behcet's Disease N/A
Completed NCT03264391 - Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography
Completed NCT04386824 - Erectile Dysfunction in Patients With Non Ocular Behçet's Disease
Completed NCT03962335 - Gut Microbiota and Behcet's Syndrome: a Dietary Intervention Trial (MAMBA Study) N/A
Completed NCT01532570 - Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions Phase 3
Not yet recruiting NCT04186559 - Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers Phase 2
Terminated NCT04218565 - Golimumab for the Treatment of Refractory Behcet's Uveitis Phase 2
Recruiting NCT05200715 - AutoInflammatory Disease Alliance Registry (AIDA)
Completed NCT05098678 - Zinc Supplementation and Behçet's Syndrome N/A
Completed NCT00866359 - A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease Phase 2
Completed NCT00483184 - Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease Phase 2
Completed NCT05032248 - Uses of Tacrolimus in Behcet Disease N/A