Behcet SyndromeNCT03747354
Assessment of Disease Activity in Behcet by Complete Blood Count
A study testing blood samples in people with Behcet Syndrome, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Behcet Syndrome
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Patient diagnosed as behcet disease by a rheumatologist
- Age from 18 to 70 years old
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Behcet Syndrome
- Being tested
- blood samples
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesDiagnostic test
blood samples
| Study group | Role | What they receive |
|---|---|---|
| complete blood count | Active comparator | blood samples will be taken from patient and complete blood count is done early morning Receives: Diagnostic Test: blood samples |
| erythrocyte sedimentation rate | Active comparator | blood samples will be taken from patient and erythrocyte sedimentation rate is done Receives: Diagnostic Test: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behcet SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esraa omar ali, Assiut University
- Investigators
- esraa omar, master, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747354
- Sponsor's protocol ID
- disease activity in behcet
- Status last verified
- Nov 2018
- First submitted
- 11 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28538403
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum (PLR), (LMR), (MPV) and (NLR) in Behcet Disease and Their Correlation With Disease Activity
- ClinicalTrials.gov ID
- NCT03747354
- Acronym / sponsor ID
- disease activity in behcet
- Conditions
- Behcet Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete blood count | Active comparator | Diagnostic Test: blood samplesblood samples will be taken from patient and complete blood count is done early morning |
| erythrocyte sedimentation rate | Active comparator | Diagnostic Test: blood samplesblood samples will be taken from patient and erythrocyte sedimentation rate is done |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -Patient diagnosed as behcet disease by a rheumatologist
- Age from 18 to 70 years old
Key exclusion criteria (6 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesblood samples | Diagnostic test | complete blood count, erythrocyte sedimentation rate |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Background: PubMed 28538403Jiang 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.
- Individual participant dataSharing planned: No
Related trials for Behcet Syndrome
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Not yet recruitingPhase 2
Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
Behçet's Syndrome, Behçet's Syndrome (BS)
RecruitingPhase 2
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Behcet Syndrome, Intestinal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
esraa omar, master study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Behcet Syndrome, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact esraa omar, master (01142171590, drmtahtawy2017@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum (PLR), (LMR), (MPV) and (NLR) in behcet disease and their correlation with disease activity. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03747354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.