NCT06272929

Brief 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. To assess the correlation between serum elafin and vascular affection and their relation with disease activity.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

February 16, 2024

Last Update Submit

February 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    within one year

Study Arms (2)

45 patients with behcet disease

Device: doppler ultrasound

45 healthy participants

Device: doppler ultrasound

Interventions

doppler US

45 healthy participants45 patients with behcet disease

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed as BD. Age of all participants (20-45) years.

You may qualify if:

  • Patients diagnosed as BD. Age of all participants (20-45) years.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 21124084BACKGROUND
  • Kutlay 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.

    PMID: 37822392BACKGROUND
  • Yazici 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.

    PMID: 34531393BACKGROUND

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assiut

Study Record Dates

First Submitted

February 16, 2024

First Posted

February 22, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

February 22, 2024

Record last verified: 2024-02