BehçetNCT03853135
Assessment of Endocan Serum Levels in Patients With Behcet Disease
An observational study of Behçet, run by Benha University at 1 site in Egypt.
Trial summary
The aim of our study was to assess serum endocan levels in patients with Behcet disease and to correlate it with various disease clinical and laboratory parameters of disease activity as well as carotid intima media thickness. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behçet
- What is being tested?
- measurement of serum endocan
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Feb 2019to 16 Dec 2019
- Phase
- Observational
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will be carried out on two groups: • Group (I): Forty two patients diagnosed to have Behcets disease fulfilling the International Criteria for BD . Group (II): including 42 age and sex matching healthy volunteers as control group.
Who may be able to join
- patients with Behcets disease fulfilling the International Criteria for BD .
Who cannot join
- infection
- malignancy
- other connective tissue disease
- chronic liver disease
- chronic kidney disease
- Diabetes mellitus
- hypertension
- hyperlipidemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Endocan Serum Levels in Patients With Behcet Disease: Relation to Clinical Parameters and Disease Status
The aim of our study was to assess serum endocan levels in patients with Behcet disease and to correlate it with various disease clinical and laboratory parameters of disease activity as well as carotid intima media thickness.
Read the detailed description
This study will be carried out on two groups:
- Group (I): Forty two patients diagnosed to have Behcets disease fulfilling the International Criteria for BD .
Group (II): including 42 age and sex matching healthy volunteers as control group.
(A) Clinical evaluation
- Complete history taking.
- Thorough clinical examination including opthalmologic evaluation .
- Disease activity using The Behcet's disease current activity form (BD-DAF) . (B) Laboratory assessment:
All patients will be subjected to the following measurements:
- ESR
- CRP
- CBC
- liver and kidney function tests
- Serum Endocan level e)triglycrides f) cholestrol C) carotid intima media thickness
- Conditions
- Behçet
- Being tested
- measurement of serum endocan
- Keywords
- Behçet disease, endocan
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of serum endocanDiagnostic test
Also called endothelial cell-specific molecule 1
measurement of serum levels of endocan
| Study group | Role | What they receive |
|---|---|---|
| Behçet group | Forty two patients diagnosed to have Behçet disease fulfilling the International Study Group Criteria for Behçet disease in whom measurement of serum endocan levels will be performed. Receives: Diagnostic Test: measurement of serum endocan | |
| control group | including 42 age and sex matching healthy volunteers as control group in whom measurement of serum endocan levels will be performed. Receives: Diagnostic Test: measurement of serum endocan |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Behcet's disease current activity form (BDCAF)
One point is given to the presence of different organ involvement over the 4 weeks prior to assessment as follows: headache, mouth ulcers, genital ulcers, skin lesions , joint involvement , gastrointestinal symptoms , eye involvement , nervous system involvement , and major vessel involvement.The total score will be out of 12 and higher score indicates worse outcome. we will assess the relation between serum endocan level and BDCAF
Measured: : through study completion, an average of 6 months
Erythrocyte sedimentation rate (ESR)
ESR measured in mm/1st hour by westergren method. we will assess the relation between serum endocan level and ESR
Measured: : through study completion, an average of 6 months
C reactive protein (CRP)
CRP measured in mg/L using nephlometry. we will assess the relation between serum endocan level and CRP
Measured: : through study completion, an average of 6 months
carotid intima media thickness
Color Doppler ultrasonography was performed for both common carotid arteries in a longitudinal orientation and measured with millimeter
Measured: : through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start27 Feb 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehçetStudies of the same condition, open and under way.
- More trials run by Benha 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Ahmed Salaheldeen Hassan, Benha University
- Investigators
- Waleed Hassan, MD, Principal investigator, Benha university- Qaluibya- Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853135
- Sponsor's protocol ID
- BenhaU22019
- Status last verified
- Jan 2020
- First submitted
- 22 Feb 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Endocan Serum Levels in Patients With Behcet Disease: Relation to Clinical Parameters and Disease Status
- ClinicalTrials.gov ID
- NCT03853135
- Acronym / sponsor ID
- BenhaU22019
- Conditions
- Behçet
- Keywords
- Behçet disease, endocan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 25 Feb 2019 (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.
The aim of our study was to assess serum endocan levels in patients with Behcet disease and to correlate it with various disease clinical and laboratory parameters of disease activity as well as carotid intima media thickness.
Detailed description
This study will be carried out on two groups:
- Group (I): Forty two patients diagnosed to have Behcets disease fulfilling the International Criteria for BD .
Group (II): including 42 age and sex matching healthy volunteers as control group.
(A) Clinical evaluation
- Complete history taking.
- Thorough clinical examination including opthalmologic evaluation .
- Disease activity using The Behcet's disease current activity form (BD-DAF) . (B) Laboratory assessment:
All patients will be subjected to the following measurements:
- ESR
- CRP
- CBC
- liver and kidney function tests
- Serum Endocan level e)triglycrides f) cholestrol C) carotid intima media thickness
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behçet group | – | Diagnostic Test: measurement of serum endocanForty two patients diagnosed to have Behçet disease fulfilling the International Study Group Criteria for Behçet disease in whom measurement of serum endocan levels will be performed. |
| control group | – | Diagnostic Test: measurement of serum endocanincluding 42 age and sex matching healthy volunteers as control group in whom measurement of serum endocan levels will be performed. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be carried out on two groups: • Group (I): Forty two patients diagnosed to have Behcets disease fulfilling the International Criteria for BD . Group (II): including 42 age and sex matching healthy volunteers as control group.
Key inclusion criteria (1 listed)
- patients with Behcets disease fulfilling the International Criteria for BD .
Key exclusion criteria (8 listed)
- infection
- malignancy
- other connective tissue disease
- chronic liver disease
- chronic kidney disease
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 |
|---|---|---|
| measurement of serum endocanAlso: endothelial cell-specific molecule 1measurement of serum levels of endocan | Diagnostic test | Behçet group, control group |
Primary outcome
the Behcet's disease current activity form (BDCAF)
Time frame: : through study completion, an average of 6 months
One point is given to the presence of different organ involvement over the 4 weeks prior to assessment as follows: headache, mouth ulcers, genital ulcers, skin lesions , joint involvement , gastrointestinal symptoms , eye involvement , nervous system involvement , and major vessel involvement.The total score will be out of 12 and higher score indicates worse outcome. we will assess the relation between serum endocan level and BDCAF
Erythrocyte sedimentation rate (ESR)
Time frame: : through study completion, an average of 6 months
ESR measured in mm/1st hour by westergren method. we will assess the relation between serum endocan level and ESR
C reactive protein (CRP)
Time frame: : through study completion, an average of 6 months
CRP measured in mg/L using nephlometry. we will assess the relation between serum endocan level and CRP
carotid intima media thickness
Time frame: : through study completion, an average of 6 months
Color Doppler ultrasonography was performed for both common carotid arteries in a longitudinal orientation and measured with millimeter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
Related trials for Behçet
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Not yet recruitingObservational study
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
Pericarditis, Tako-TSUBO Cardiomyopathy
RecruitingPhase 3
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Behçet Disease
Recruiting
Deployment o the Multidisciplinary Prospective Cohort Imminent
Chronic Inflammatory Disease, Angioedema
Active, not recruitingPhase 4
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
Rheumatoid Arthritis, Spondylitis, Ankylosing
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.
Waleed Hassan, MD principal investigator
Benha university- Qaluibya- Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet, run by Benha University at 1 site in Egypt.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Behcet's disease current activity form (BDCAF) (time frame: : through study completion, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2020.