Behcet Disease and Vascular AffectionNCT06272929
Serum Elafin and Vascular Affection in Behcet Disease
An observational study of Behcet Disease and Vascular Affection, run by Assiut University.
Trial summary
To measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Behcet Disease and Vascular Affection
- What is being tested?
- doppler ultrasound
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Apr 2025
- 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 20 to 45 years
- All sexes
- Adult
Study population: Patients diagnosed as BD. Age of all participants (20-45) years.
Who may be able to join
- Patients diagnosed as BD. Age of all participants (20-45) years.
Who cannot join
- Age <20 or >45 years. Other autoimmune diseases. Cardiovascular diseases (heart failure, myocardial ischemia). Possible related risk factors (e.g. diabetes, dyslipidemia, smoking). chronic conditions (e.g. chronic kidney disease, malignancy, autoimmune diseases).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serum Elafin: A Biomarker in Behcet Disease and Its Relation to Vascular Involvement and Disease Activity
To measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity.
To assess the correlation between serum elafin and vascular affection and their relation with disease activity.
Read the detailed description
Behçet's disease (BD) is a chronic, multisystemic, inflammatory disease characterized by recurrent oral and genital ulcers and multiple systemic involvements. Elafin is a serine protease inhibitor produced mainly by epithelial cells. Its expression is upregulated by proinflammatory cytokines such as IL-1β and TNF-α that are potent stimulants of neutrophil activation, it counteracts the destructive effects of neutrophil elastase .Interestingly, previous reports documented the role of serum elafin in the pathogenesis of BD.In fact, vascular complications may be one of the earliest manifestations leading to the diagnosis of BD. There is no reliable tool to identify vascular wall inflammation in BD, except for detecting intravascular thrombosis with ultrasonography (US). Previous studies investigated arterial vessel wall thickness with US (mostly in carotid arteries) in BD . Venous wall inflammation presents with deep vein thrombosis and superficial thrombophlebitis . It was stated that lower extremity vein wall thickness (VWTs)was increased in BD patients independently of vascular activity and important in the diagnosis . However, studies in the literature evaluated only lower extremity VWTs, whereas the relationship of VWT with disease activity has not been emphasized .
- Conditions
- Behcet Disease and Vascular Affection
- Being tested
- doppler ultrasound
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doppler ultrasoundDevice
doppler US
| Study group | Role | What they receive |
|---|---|---|
| 45 patients with behcet disease | Not described Receives: Device: doppler ultrasound | |
| 45 healthy participants | Not described Receives: Device: doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the level of serum Elafin in patients with BD in comparison to healthy participants.
Measuring the level of serum Elafin in patients with BD in comparison to healthy participants.
Measured: within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Behcet Disease and Vascular AffectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lobna Amer Araby Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272929
- Sponsor's protocol ID
- behcet and vascular
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calamia KT, Schirmer M, Melikoglu M. Major vessel involvement in Behcet's disease: an update. Curr Opin Rheumatol. 2011 Jan;23(1):24-31. doi: 10.1097/BOR.0b013e3283410088.
PubMed 21124084Kutlay A, Kose AA. Serum Elafin as a Potential Marker of Disease Activity in Behcet's Disease. Indian J Dermatol. 2023 Jul-Aug;68(4):372-376. doi: 10.4103/ijd.ijd_913_22.
PubMed 37822392Yazici Y, Hatemi G, Bodaghi B, Cheon JH, Suzuki N, Ambrose N, Yazici H. Behcet syndrome. Nat Rev Dis Primers. 2021 Sep 16;7(1):67. doi: 10.1038/s41572-021-00301-1.
PubMed 34531393
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Elafin: A Biomarker in Behcet Disease and Its Relation to Vascular Involvement and Disease Activity
- ClinicalTrials.gov ID
- NCT06272929
- Acronym / sponsor ID
- behcet and vascular
- Conditions
- Behcet Disease and Vascular Affection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 22 Feb 2024 (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 measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity.
To assess the correlation between serum elafin and vascular affection and their relation with disease activity.
Detailed description
Behçet's disease (BD) is a chronic, multisystemic, inflammatory disease characterized by recurrent oral and genital ulcers and multiple systemic involvements. Elafin is a serine protease inhibitor produced mainly by epithelial cells. Its expression is upregulated by proinflammatory cytokines such as IL-1β and TNF-α that are potent stimulants of neutrophil activation, it counteracts the destructive effects of neutrophil elastase .Interestingly, previous reports documented the role of serum elafin in the pathogenesis of BD.In fact, vascular complications may be one of the earliest manifestations leading to the diagnosis of BD. There is no reliable tool to identify vascular wall inflammation in BD, except for detecting intravascular thrombosis with ultrasonography (US). Previous studies investigated arterial vessel wall thickness with US (mostly in carotid arteries) in BD . Venous wall inflammation presents with deep vein thrombosis and superficial thrombophlebitis . It was stated that lower extremity vein wall thickness (VWTs)was increased in BD patients independently of vascular activity and important in the diagnosis . However, studies in the literature evaluated only lower extremity VWTs, whereas the relationship of VWT with disease activity has not been emphasized .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 45 patients with behcet disease | – | Device: doppler ultrasound |
| 45 healthy participants | – | Device: doppler ultrasound |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients diagnosed as BD. Age of all participants (20-45) years.
Key inclusion criteria (1 listed)
- Patients diagnosed as BD. Age of all participants (20-45) years.
Key exclusion criteria (1 listed)
- Age <20 or >45 years. Other autoimmune diseases. Cardiovascular diseases (heart failure, myocardial ischemia). Possible related risk factors (e.g. diabetes, dyslipidemia, smoking). chronic conditions (e.g. chronic kidney disease, malignancy, autoimmune 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 |
|---|---|---|
| doppler ultrasounddoppler US | Device | 45 healthy participants, 45 patients with behcet disease |
Primary outcome
Measuring the level of serum Elafin in patients with BD in comparison to healthy participants.
Time frame: within one year
Measuring the level of serum Elafin in patients with BD in comparison to healthy participants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Background: PubMed 21124084Calamia KT, Schirmer M, Melikoglu M. Major vessel involvement in Behcet's disease: an update. Curr Opin Rheumatol. 2011 Jan;23(1):24-31. doi: 10.1097/BOR.0b013e3283410088.
- Background: PubMed 37822392Kutlay A, Kose AA. Serum Elafin as a Potential Marker of Disease Activity in Behcet's Disease. Indian J Dermatol. 2023 Jul-Aug;68(4):372-376. doi: 10.4103/ijd.ijd_913_22.
- Background: PubMed 34531393Yazici Y, Hatemi G, Bodaghi B, Cheon JH, Suzuki N, Ambrose N, Yazici H. Behcet syndrome. Nat Rev Dis Primers. 2021 Sep 16;7(1):67. doi: 10.1038/s41572-021-00301-1.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Behcet Disease and Vascular Affection, 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 1 inclusion and 1 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 22 Feb 2024. 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 Lobna Amer, MD (01019313530, lobnaamer20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the level of serum Elafin in patients with BD in comparison to healthy participants. (time frame: within one year). 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 NCT06272929, which also lists 3 linked publications.
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 22 Feb 2024.