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Assessment of Endocan Serum Levels in Patients With Behcet Disease

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ClinicalTrials.gov Identifier: NCT03853135
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Waleed Ahmed Salaheldeen Hassan, Benha University

Brief 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 as well as disease activity.

Condition or disease Intervention/treatment
Behçet Diagnostic Test: measurement of serum endocan

Detailed Description:

This study will be carried out on two groups:

• Group (I): Forty patients diagnosed to have Behcets disease fulfilling the International Criteria for BD .

Group (II): including 20 age and sex matching healthy volunteers as control group.

(A) Clinical evaluation

  1. Complete history taking.
  2. Thorough clinical examination including opthalmologic evaluation .
  3. Disease activity using The Behcet's disease current activity form (BD-DAF) . (B) Laboratory assessment:

All patients will be subjected to the following measurements:

  1. ESR
  2. CRP
  3. CBC
  4. liver and kidney function tests

d) Serum Endocan level


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment of Endocan Serum Levels in Patients With Behcet Disease: Relation to Clinical Parameters and Disease Status
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : May 25, 2019
Estimated Study Completion Date : May 25, 2019


Group/Cohort Intervention/treatment
Behçet group
Forty 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.
Diagnostic Test: measurement of serum endocan
measurement of serum levels of endocan
Other Name: endothelial cell-specific molecule 1

control group
including 20 age and sex matching healthy volunteers as control group in whom measurement of serum endocan levels will be performed.
Diagnostic Test: measurement of serum endocan
measurement of serum levels of endocan
Other Name: endothelial cell-specific molecule 1




Primary Outcome Measures :
  1. the Behcet's disease current activity form (BDCAF) [ Time Frame: : through study completion, an average of 3months ]
    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

  2. Erythrocyte sedimentation rate (ESR) [ Time Frame: : through study completion, an average of 3months ]
    ESR measured in mm/1st hour by westergren method. we will assess the relation between serum endocan level and ESR

  3. C reactive protein (CRP) [ Time Frame: : through study completion, an average of 3months ]
    CRP measured in mg/L using nephlometry. we will assess the relation between serum endocan level and CRP


Biospecimen Retention:   Samples Without DNA
serum samples


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

This study will be carried out on two groups:

• Group (I): Forty patients diagnosed to have Behcets disease fulfilling the International Criteria for BD .

Group (II): including 20 age and sex matching healthy volunteers as control group.

Criteria

Inclusion Criteria:

  • patients with Behcets disease fulfilling the International Criteria for BD .

Exclusion Criteria:

  • infection
  • malignancy
  • other connective tissue disease
  • chronic liver disease
  • chronic kidney disease

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): NCT03853135


Contacts
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Contact: Waleed Hassan, MD 01095000886 ext +2 waleed22101979@yahoo.com
Contact: Eman Behiry, MD 00201006216116 emangamal24@yahoo.com

Locations
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Egypt
Benha University Hospital Recruiting
Banhā, Qalubiya, Egypt, 13518
Contact: Ali Fouda, MD    00201066640220    ali71960@hotmail.com   
Contact: Waleed Hassan, MD    00201095000886    waleed22101979@yahoo.com   
Sub-Investigator: Eman gamal, MD         
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: Waleed Hassan, MD Benha university- Qaluibya- Egypt

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Responsible Party: Waleed Ahmed Salaheldeen Hassan, Assistant professor, Benha University
ClinicalTrials.gov Identifier: NCT03853135     History of Changes
Other Study ID Numbers: BenhaU22019
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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

Keywords provided by Waleed Ahmed Salaheldeen Hassan, Benha University:
Behçet disease
endocan

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