BehçetNCT06060275
Neurofilament Light Chain as a Potential Marker in Behcet's Disease
An observational study of Behçet, run by Assiut University.
Trial 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 ). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Behçet
- What is being tested?
- serum sample and nerve conduction study and cerebrospinal fluid study
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: - any adult patient satisfied International study group criteria of Behcet's disease
Who may be able to join
- any adult patient satisfied International study group criteria of Behcet's disease
Who cannot join
- Patients with definite diagnosis for any other causes affecting central and peripheral nervous system eg….
- Infection (Viral, Bacterial, Fungal)
- Toxic
- Drug induced
- Other diseases (Multiple sclerosis, Neuromyelitis Optica)
- Trauma
Show all 10Show fewer
- other autoimmune diseases
- Diabetic patients
- purely degenerative diseases
- Tumours
Trial locations and contacts
No sites are listed yet.
About this study
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 ).
Read the 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.
- Conditions
- Behçet
- Being tested
- serum sample and nerve conduction study and cerebrospinal fluid study
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum sample and nerve conduction study and cerebrospinal fluid studyDiagnostic test
serum sample and cerebrospinal fluid study to detect Neurofilament light chain Nerve conduction study
What is being measured
The primary outcome is the main question the study is designed to answer.
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
compare the level of NFL in serum between groups of Behcet patients with or without central and peripheral Nervous system affection
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BehçetStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayera Ahmed Abdelhamed, Assiut University
- Investigators
- Yasmin Makarem, Study director, Assiut UniversityRania Gamal, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060275
- Sponsor's protocol ID
- Neurofilament in behcet
- Status last verified
- Oct 2023
- First submitted
- 23 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27351485Gheita 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.
PubMed 31119493Karaaslan 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.
PubMed 36326394Maalmi 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.
PubMed 36472640Engel 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.
PubMed 34707690Tjensvoll 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.
PubMed 33128084
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofilament Light Chain as a Potential Marker in Behcet's Disease
- ClinicalTrials.gov ID
- NCT06060275
- Acronym / sponsor ID
- Neurofilament in behcet
- Conditions
- Behçet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - any adult patient satisfied International study group criteria of Behcet's disease
Key inclusion criteria (1 listed)
- any adult patient satisfied International study group criteria of Behcet's disease
Key exclusion criteria (10 listed)
- Patients with definite diagnosis for any other causes affecting central and peripheral nervous system eg….
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum sample and nerve conduction study and cerebrospinal fluid studyserum sample and cerebrospinal fluid study to detect Neurofilament light chain Nerve conduction study | Diagnostic test | – |
Primary outcome
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
Time frame: baseline
compare the level of NFL in serum between groups of Behcet patients with or without central and peripheral Nervous system affection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Background: PubMed 27351485Davatchi 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.
- Background: PubMed 31119493Gheita 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.
- Background: PubMed 36326394Karaaslan 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.
- Background: PubMed 36472640Maalmi 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.
- Background: PubMed 34707690Engel 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.
- Background: PubMed 33128084Tjensvoll 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmin Makarem study director
Assiut University
Rania Gamal principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nayera Abdelhamed (+0201063061540, nana.ahmed97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06060275, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.