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临床试验/NCT06451471
NCT06451471已完成不适用

Assessment of Serum Galectin-3 Level as an Indicator of Subclinical Inflammation in Patients With Familial Mediterranean Fever

Turkish League Against Rheumatism1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
154
试验地点
1
主要终点
Serum Galectin-3 Levels

研究概览

简要总结

The goal of this observational study is to learn about the relationship between serum Galectin-3 levels and subclinical inflammation in patients with Familial Mediterranean Fever (FMF). The main questions it aims to answer are:

  • Are serum Galectin-3 levels higher in FMF patients compared to healthy controls?
  • Is there a positive correlation between serum Galectin-3 levels and Serum Amyloid A (SAA) protein levels in FMF patients?

Participants will:

  • Provide blood samples to measure serum Galectin-3 and SAA levels.
  • Complete a sociodemographic and clinical data form.
  • Fill out the FMF Quality of Life (QoL) scale.

Researchers will compare FMF patients and healthy controls to see if there are significant differences in serum Galectin-3 levels and to determine the correlation between Galectin-3 and SAA protein levels in FMF patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for the Patient Group:
  • Aged between 18 and 65 years,
  • Able to provide written informed consent for the study,
  • Diagnosed with Familial Mediterranean Fever (FMF) according to the Tel Hashomer criteria and not currently experiencing an attack (with at least 15 days since the last attack).
  • Inclusion Criteria for the Healthy Control Group:
  • Aged between 18 and 65 years,
  • Able to provide written informed consent for the study,

排除标准

  • Exclusion Criteria for the Patient Group:
  • Presence of known inflammatory diseases other than FMF,
  • Presence of known systemic, chronic, severe medical conditions,
  • Presence of active infection,
  • Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
  • Being pregnant or in the lactation period.
  • Exclusion Criteria for the Healthy Control Group:
  • Presence of known systemic, chronic, severe medical conditions,
  • Presence of inflammatory diseases,
  • Presence of active infection,
  • Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
  • Being pregnant or in the lactation period. -

结局指标

主要结局

Serum Galectin-3 Levels

时间窗: 2022

Comparison of serum Galectin-3 levels between FMF patients and healthy controls to determine if there is a significant difference.

次要结局

  • Serum Amyloid A (SAA) Levels(2022)
  • Clinical Variables(2022)
  • Correlation Analysis(2022)

研究者

发起方
Turkish League Against Rheumatism
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oguzhan Lacin

Medical Doctor

Turkish League Against Rheumatism

研究点 (1)

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