Neurofilament Light Chain as a Potential Marker in Behcet's Disease

Not yet recruiting

• Conditions: Behçet

• Registration Number: NCT06060275
• Lead Sponsor: Assiut University

Brief Summary

To determine the role of neurofilament light chain in Behçet's disease with or without neurological affection and its relation to neurological manifestation (either peripheral or central ).

Detailed Description

Behçet disease is a multisystemic autoinflammatory disorder characterized by recurrent oral and genital ulcer, eye affection, thrombosis and many systems can be affected with the most serious being the nervous system affection which is commonly called neuro-Behçet's disease (NBD) In Ghita et al, the prevalence of Behcet disease in Egypt was estimated to be 3.6/100,000 with CNS affection occurred in about 13.1% of the patients , while in other study performed in Egypt the peripheral neuropathy affection reached 53.3% of the patients with insignificant difference between both upper and lower limb but sensory affection was manifested more than motor affection in those patients.

Neurofilament light chain (NFL) is a neuronal cytoplasmic protein, which was assumed to have a role as a prognostic biomarker in several neuroimmunological and neurodegenerative diseases. It was documented in peripheral nerve affection of patients with diabetes mellitus and GuillainBarré syndrome. Recently, some studies documented the presence of high level of NFL chain in serum of neurolupus and primary sjogren's diseases , more over in 2022, Karaaslan et al. measured NFL in the cerebrospinal fluid (CSF) and found it high in neurobehcet patients and assumed that it can predict the prospective cognitive and somatic disability in NBD patients.

So, the investigators aim at our study to assess the role of NFL chain in serum of behcet disease in those with and without peripheral and central nervous system affection and its relation to neurological manifestation.

Study Timeline

• Study First Submitted: 2023-09-23
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-09-29
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11
• Study Start: 2024-01-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• any adult patient satisfied International study group criteria of Behcet's disease

Exclusion Criteria

• Patients with definite diagnosis for any other causes affecting central and peripheral nervous system eg....

  1. Infection (Viral, Bacterial, Fungal)
  2. Toxic
  3. Drug induced
  4. Other diseases (Multiple sclerosis, Neuromyelitis Optica)
  5. Trauma
  6. other autoimmune diseases
  7. Diabetic patients
  8. purely degenerative diseases
  9. Tumours

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
aim at our study to assess the role of NFL chain in serum of behcet disease in those with and without peripheral and central nervous system affection and its relation to neurological manifestation	baseline	compare the level of NFL in serum between groups of Behcet patients with or without central and peripheral Nervous system affection