Clinical trial NCT06730958: Evaluation of Serum Follistatin-Like Protein 1 Levels in Behcet's Disease and Its Association With Disease Activity
Official title: Evaluation of Serum Follistatin-Like Protein 1 Levels in Behcet's Disease and Its Association With Disease Activity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Behcet Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease

Brief summary: Behçet's disease (BD) is a multi-system auto inflammatory disorder with vasculitic features.

The exact etiological of BD is still obscure, although environmental and genetics factors have been found to be involved in disease pathogenesis.FSTL-1 can act as diagnostic and prognostic biomarkers for Some inflammatory autoimmune diseases including BD.

Detailed description: Behçet's disease (BD) is a multi-system auto inflammatory disorder with vasculitic features Clinical manifestation of BD includes recurrent oral and genital ulcerations, uveitis, skin lesions, vascular, neurological, and gastrointestinal manifestations.The exact etiological of BD is still obscure, although environmental and genetics factors have been found to be involved in disease pathogenesis.

Most of BD manifestations have features of systemic perivasculitis. Cell-mediated immunity has a significant role in BD pathogenesis . Activation of Type 1 helper T (Th1) cell will increase levels of circulating T-lymphocytes, with subsequent increase in the levels of proinflammatory cytokines accounting for most of BD symptoms. These proinflammatory cytokines may be used as an indicator of disease severity. Also Increased macrophage activation, neutrophil chemotaxis, and phagocytosis have been described in BD lesion.

Indeed, the need for studying biomarkers that may drive inflammatory pathways involved in BD pathogenesis is crucial.

Follistatin-like proteins (FLP) belong to the family of acidic cysteine-rich secreted glycoproteins (SPARC) that are highly homologous to the activin-binding protein, follistatin (FST)(7). this group of proteins include five types: FSTL1, FSTL2, FSTL3, FSTL4 and FSTL5.

Follistatin-like protein 1 (FSTL-1) is a soluble gly¬coprotein expressed by mesenchymal cells. It has been involved in various signaling pathways and biological processes. FSTL1 has dual effect in inflammatory processes and has been evaluated in some laboratory models and can serve as pro-inflammatory and anti-inflammatory markers.

During the acute inflammation FSL1 may act as an anti-inflammatory factor, while they exert a pro-inflammatory effect in chronic inflammation. This dual effect has been explained by activation of several signaling pathways.

Although, additional exogenous and endogenous factors, may be involved in such regulation. Increased serum levels FSTL1 levels were found in some of autoimmune systemic diseases including rheumatoid arthritis, Sjogren's syndrome and osteoarthritis. Moreover, the In¬creased serum levels of FSTL-1 where found to be positively correlated with disease activity in some autoim¬mune diseases, including, rheumatoid arthritis (RA), juvenile idiopathic arthritis and systemic lupus ery¬thematosus (SLE).

Based on the above mention findings, FSTL-1 can act as diagnostic and prognostic biomarkers for Some inflammatory autoimmune diseases including BD.

Eligibility criteria: Inclusion Criteria:

* Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease

Exclusion Criteria:

* Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).

Primary outcomes:
measure: FSL1in the serum of BD patients
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
Study officials:
affiliation: Assiut University
name: Sara Farrag, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yazici Y, Hatemi G, Bodaghi B, Cheon JH, Suzuki N, Ambrose N, Yazici H. Behcet syndrome. Nat Rev Dis Primers. 2021 Sep 16;7(1):67. doi: 10.1038/s41572-021-00301-1.
citation: Tortoriello DV, Sidis Y, Holtzman DA, Holmes WE, Schneyer AL. Human follistatin-related protein: a structural homologue of follistatin with nuclear localization. Endocrinology. 2001 Aug;142(8):3426-34. doi: 10.1210/endo.142.8.8319.
citation: Kaplan H, Calis M, Yazici C, Gunturk I, Cuce I, Senel AS. Are follistatin-like protein 1 and follistatin-like protein 3 associated with inflammatory processes in patients with familial Mediterranean fever? North Clin Istanb. 2023 Jun 6;10(3):306-313. doi: 10.14744/nci.2022.54189. eCollection 2023.