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临床试验/NCT05868538
NCT05868538已完成不适用

Evaluation of Calprotectin and Ischemia Modified Albumin Serum Levels as Biomarkers to Measure Disease Activity in Behçet's Disease

Mansoura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
BD activity was evaluated using BD Current Activity Form (BDCAF).

研究概览

简要总结

Behçet's Disease activity was evaluated using BD Current Activity Form (BDCAF). Serum calprotectin and IMA concentrations were compared among active BD cases, inactive BD cases and control subjects.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • new case of Behçet's disease available medical record Well known duration of BD, Well known current treatment used Well known current organ involvement

排除标准

  • concomitant autoimmune or auto-inflammatory disorder; acute or chronic infections; cancer; diabetes; heart failure; gestation or up to six months after birth

结局指标

主要结局

BD activity was evaluated using BD Current Activity Form (BDCAF).

时间窗: 3 years

BD activity was assessed with BDCAF which assesse clinical characteristics present during the previous one month before evaluation. BDCAF include the following components: headaches; mouth ulcers; erythema; genital ulcers; arthritis; arthralgia; nausea/emesis/pain in abdomen; rectal bleeding; diarrhea; and new ocular, vascular, and nervous symptoms. Each component takes a score of (0) if absent or (1) if present \[30\]. The total BDCAF score was calculated by adding up the positive components (maximum score = 12). A BDCAF patient index score ≥2 was considered as active BD, while a score less than 2 was considered as inactive BD

Ischaemia Modified Albumin (IMA) serum concentrations

时间窗: 3 years

IMA was quantified based on albumin cobalt binding colorimetric assay according to Bar-Or and colleagues and the levels were expressed in absorbance units (ABSU). To obtain corrected IMA values, the equation (individual albumin level/median albumin level of population) × IMA ABSU value was applied. Unit of measurment ( kU/L)

Serum calprotectin concentrations

时间窗: 3 years

Blood samples were withdrawn from all participants 12 h after fasting. Samples underwent centrifugation at 4000 rpm for ten minutes. The sera were collected and kept at -80°C till analysis. Serum calprotectin concentrations were quantified utilizing a commercial calprotectin ELISA kit (Hycult Biotech Inc, US) based on manufacturer's instructions. Levels of high-sensitivity CRP (hsCRP) and albumin were detected using the immunoturbidimetric technique. Unit of measurment (μg/ml )

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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