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Status unknownNCT06060275Updated Oct 11, 2023

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

An observational study in Behçet, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-11.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 75 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Behçet

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In context

Behcet Syndrome

138 studies on the registry are indexed under Behcet Syndrome; 43 are open to participants now.

This study's planned enrollment of 60 is below the median of 90 across 64 observational studies indexed under Behcet Syndrome.

Browse Behcet Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testserum sample and nerve conduction study and cerebrospinal fluid study

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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 27351485 ↗
  • 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. PubMed 31119493 ↗
  • 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. PubMed 36326394 ↗
  • 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. PubMed 36472640 ↗
  • 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. PubMed 34707690 ↗
  • 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. PubMed 33128084 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2024; primary completion for Oct 2024, 9 months later.

Of 23 observational studies under Behcet Syndrome, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 81. This study's planned 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2023
First posted
Sep 29, 2023
StartEst.
Jan 1, 2024
Primary completionEst.
Oct 1, 2024
CompletionEst.
Nov 1, 2024
Last update
Oct 11, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06060275
Lead sponsor
Assiut University
Responsible party
Nayera Ahmed Abdelhamed (Nayera Ahmed Abdelhamed, Assiut University) — Principal investigator
First posted
Sep 29, 2023
Start date
Jan 1, 2024 (estimated)
Primary completion
Oct 1, 2024 (estimated)
Completion
Nov 1, 2024 (estimated)
Last update
Oct 11, 2023

Study contacts

Nayera Abdelhamed
Contact
nana.ahmed97@gmail.com
+0201063061540
Amira Alsonbaty
Contact
dramiramelsonbaty@gmail.com
01060220990
Yasmin Makarem
study director · Assiut University
Rania Gamal
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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