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

NCT ID: NCT06060275

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Behçet

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

serum sample and nerve conduction study and cerebrospinal fluid study

serum sample and cerebrospinal fluid study to detect Neurofilament light chain Nerve conduction study

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nayera Ahmed Abdelhamed

Nayera Ahmed Abdelhamed

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yasmin Makarem

Role: STUDY_DIRECTOR

Assiut University

Rania Gamal

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nayera Abdelhamed

Role: CONTACT

+0201063061540

Amira Alsonbaty

Role: CONTACT

01060220990

References

Explore related publications, articles, or registry entries linked to this study.

Davatchi F, Chams-Davatchi C, Shams H, Shahram F, Nadji A, Akhlaghi M, Faezi T, Ghodsi Z, Sadeghi Abdollahi B, Ashofteh F, Mohtasham N, Kavosi H, Masoumi M. Behcet's disease: epidemiology, clinical manifestations, and diagnosis. Expert Rev Clin Immunol. 2017 Jan;13(1):57-65. doi: 10.1080/1744666X.2016.1205486. Epub 2016 Jul 11.

Reference Type BACKGROUND
PMID: 27351485 (View on PubMed)

Gheita TA, El-Latif EA, El-Gazzar II, Samy N, Hammam N, Abdel Noor RA, El-Shebeiny E, El-Najjar AR, Eesa NN, Salem MN, Ibrahim SE, El-Essawi DF, Elsaman AM, Fathi HM, Sallam RA, El-Shereef RR, Abd-Elazeem MI, Said EA, Khalil NM, Shahin D, El-Saadany HM, ElKhalifa MS, Nasef SI, Abdalla AM, Noshy N, Fawzy RM, Saad E, Moshrif AH, El-Shanawany AT, Abdel-Fattah YH, Khalil HM; Egyptian College of Rheumatology-Behcet's Disease Study Group (ECR-BDSG). Behcet's disease in Egypt: a multicenter nationwide study on 1526 adult patients and review of the literature. Clin Rheumatol. 2019 Sep;38(9):2565-2575. doi: 10.1007/s10067-019-04570-w. Epub 2019 May 22.

Reference Type BACKGROUND
PMID: 31119493 (View on PubMed)

Karaaslan Z, Sanli E, Timirci-Kahraman O, Yilmaz V, Akbayir E, Koral G, Icoz S, Gunduz T, Kucukali CI, Kurtunvu M, Tuzun E. Cerebrospinal fluid level of neurofilament light chain is associated with increased disease activity in neuro-Behcet's disease. Turk J Med Sci. 2022 Aug;52(4):1266-1273. doi: 10.55730/1300-0144.5432. Epub 2022 Aug 10.

Reference Type BACKGROUND
PMID: 36326394 (View on PubMed)

Maalmi H, Strom A, Petrera A, Hauck SM, Strassburger K, Kuss O, Zaharia OP, Bonhof GJ, Rathmann W, Trenkamp S, Burkart V, Szendroedi J, Ziegler D, Roden M, Herder C; GDS Group. Serum neurofilament light chain: a novel biomarker for early diabetic sensorimotor polyneuropathy. Diabetologia. 2023 Mar;66(3):579-589. doi: 10.1007/s00125-022-05846-8. Epub 2022 Dec 6.

Reference Type BACKGROUND
PMID: 36472640 (View on PubMed)

Engel S, Boedecker S, Marczynski P, Bittner S, Steffen F, Weinmann A, Schwarting A, Zipp F, Weinmann-Menke J, Luessi F. Association of serum neurofilament light chain levels and neuropsychiatric manifestations in systemic lupus erythematosus. Ther Adv Neurol Disord. 2021 Oct 22;14:17562864211051497. doi: 10.1177/17562864211051497. eCollection 2021.

Reference Type BACKGROUND
PMID: 34707690 (View on PubMed)

Tjensvoll AB, Lauvsnes MB, Zetterberg H, Kvaloy JT, Kvivik I, Maroni SS, Greve OJ, Beyer MK, Hirohata S, Putterman C, Alves G, Harboe E, Blennow K, Goransson LG, Omdal R. Neurofilament light is a biomarker of brain involvement in lupus and primary Sjogren's syndrome. J Neurol. 2021 Apr;268(4):1385-1394. doi: 10.1007/s00415-020-10290-y. Epub 2020 Oct 30.

Reference Type BACKGROUND
PMID: 33128084 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Neurofilament in behcet

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.