Vascular Affection in Behcet Disease | NCT06280430

Studies
Vascular Affection in Behcet Disease

NCT06280430

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Feb 28, 2024Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Behcet Disease and Vascular Involvement

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Estimated

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Apr 1, 2025Estimated

First Submitted Date

Feb 20, 2024

First Submission Date that Met QC Criteria

Feb 20, 2024

First Posted Date

Feb 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2024

Last Update Posted Date

Feb 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Within 1year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients diagnosed as behcet disease Age (20-45)

Exclusion Criteria:

age <20 and >45 Other autoimmune diseases Risk factors (ischemic heart disease, diabetes) Chronic conditions (malignancy, chronic kidney disease)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

45 patients with behcet disease aged(20-45) in comparison with 45 heathy participant s

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001528	Behcet Syndrome

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014606	Uveitis, Anterior
D015864	Panuveitis

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Patients with behcet disease
Healthy control group