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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06060275
Collaborator
(none)
60
1.3

Study Details

Study Description

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 ).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: serum sample and nerve conduction study and cerebrospinal fluid study

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, we 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Neurofilament Light Chain as a Potential Marker in Behcet's Disease
Anticipated Study Start Date :
Sep 23, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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 ) [baseline]

    compare the level of NFL in serum between groups of Behcet patients with or without central and peripheral Nervous system affection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Yasmin Makarem, Assiut University
  • Principal Investigator: Rania Gamal, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nayera Ahmed Abdelhamed, Nayera Ahmed Abdelhamed, Assiut University
ClinicalTrials.gov Identifier:
NCT06060275
Other Study ID Numbers:
  • Neurofilament in behcet
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2023