Behcet Disease and Vascular InvolvementNCT06280430
Vascular Affection in Behcet Disease
An observational study of Behcet Disease and Vascular Involvement, run by Assiut University.
Trial summary
To measure the level of serum elafin in patients with behcet disease and to assess the correlation between serum elafin and vascular affection and their relation 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 Involvement
- 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: 45 patients with behcet disease aged(20-45) in comparison with 45 heathy participant s
Who may be able to join
- patients diagnosed as behcet disease Age (20-45)
Who cannot join
- age <20 and >45 Other autoimmune diseases Risk factors (ischemic heart disease, diabetes) Chronic conditions (malignancy, chronic kidney disease)
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 behcet disease and to assess the correlation between serum elafin and vascular affection and their relation with disease activity
Read the detailed description
Behcet disease is a chronic multi systemic inflammatory disease characterized by recurrent oral and genital ulcers and multiple systemic affection . Elafin is a serine protease inhibitor produced mainly by epithelial cells . previous studies documented the role of serum elafin in pathogenesis of behcet disease.vascular complications may be one if the earliest manifestation leading to the diagnosis of behcet disease.
- Conditions
- Behcet Disease and Vascular Involvement
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with behcet disease | Not described | |
| Healthy control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the level of serum elafin in behcet patients and compare it with control group
Measure the level of serum elafin in behcet and its relation to disease activity and vascular involvement
Measured: Within 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 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.
- Other trials for Behcet Disease and Vascular InvolvementStudies 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
- NCT06280430
- Sponsor's protocol ID
- Vascular affection in behcet
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 28 Feb 2024
- 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 28 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
- NCT06280430
- Acronym / sponsor ID
- Vascular affection in behcet
- Conditions
- Behcet Disease and Vascular Involvement
- 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
- 28 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 behcet disease and to assess the correlation between serum elafin and vascular affection and their relation with disease activity
Detailed description
Behcet disease is a chronic multi systemic inflammatory disease characterized by recurrent oral and genital ulcers and multiple systemic affection . Elafin is a serine protease inhibitor produced mainly by epithelial cells . previous studies documented the role of serum elafin in pathogenesis of behcet disease.vascular complications may be one if the earliest manifestation leading to the diagnosis of behcet disease.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with behcet disease | – | – |
| Healthy control group | – | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- 45 patients with behcet disease aged(20-45) in comparison with 45 heathy participant s
Key inclusion criteria (1 listed)
- patients diagnosed as behcet disease Age (20-45)
Key exclusion criteria (1 listed)
- age <20 and >45 Other autoimmune diseases Risk factors (ischemic heart disease, diabetes) Chronic conditions (malignancy, 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.
Primary outcome
To measure the level of serum elafin in behcet patients and compare it with control group
Time frame: Within 1year
Measure the level of serum elafin in behcet and its relation to disease activity and vascular involvement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Behcet Disease and Vascular Involvement, 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 28 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?
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?
To measure the level of serum elafin in behcet patients and compare it with control group (time frame: Within 1year). 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 28 Feb 2024.