Evaluation of Serum Follistatin-Like Protein 1 Levels in Behcet's Disease and Its Association With Disease Activity

NCT06730958 | Recruiting

• 1 other identifier: SFA12024
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Behcet Syndrome

Outcome Measures

Primary Outcomes (1)

• FSL1in the serum of BD patients

  the level of FSL1in the serum of BD patients and their relation to various disease clinical and laboratory data in addition to the correlation between FSL1 level and BD activity.

  3 months

Study Arms (2)

Behçet's disease

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

Diagnostic Test: serum Follistatin-like protein 1

control group

healthy matched controls

Diagnostic Test: serum Follistatin-like protein 1

Interventions

serum Follistatin-like protein 1 DIAGNOSTIC_TEST

Serum FSL1 level Test principle The kit uses a double-antibody sandwich enzyme-linked immunosorbent assay(ELISA) to assay the level ofHuman Follistatin Like Protein 1(FSTL1) in samples. Add Follistatin Like Protein 1(FSTL1)to monoclonal antibody.Enzyme well which is pre-coated with Human Follistatin Like Protein1(FSTL1)monoclonal antibody, incubation; then, add Follistatin Like Protein 1(FSTL1)antibodies labeled with biotin, and combined with Streptavidin-HRP to form immune complex; then carry out incubation and washing again to remove the uncombined enzyme. Then add Chromogen Solution A, B, the color of the liquid changes into the blue, And at the effect of acid, the color finally becomes yellow. The chroma of color and the concentration of the Human Substance Follistatin Like Protein 1(FSTL1) of sample were positively correlated.

Behçet's disease; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, 71111, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 34531393 RESULT

• 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.

  PMID: 11459787 RESULT

• 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.

  PMID: 37435280 RESULT

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Officials

• Sara Farrag, Lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Farrag, Lecturer

CONTACT

+201097767735; sara_farrag@aun.edu.eg

Eman Mohamed, Lecturer

CONTACT

01063489998; eman202@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Rheumatology and Rehabilitation

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: January 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)