跳至主要内容
临床试验/NCT06998381
NCT06998381招募中不适用

Ethnic Specificities of S100B Protein Blood Level in Guadeloupe: Cross-sectional Study in Healthy Subjects

Centre Hospitalier Universitaire de la Guadeloupe2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年2月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
S100B and ethnicity

研究概览

简要总结

Numerous studies have demonstrated the significant contribution of S100B blood level measurement in the management of minor to moderate traumatic brain injuries, notably by reducing the number of cranial computed tomography (CT) scans by at least one-third. However, physiological blood concentrations of the S100B protein may be higher in individuals with a Black phenotype compared to those with Asian or, in particular, Caucasian phenotypes. Assessing S100B protein levels in healthy individuals will help confirm the variability of its physiological concentration according to skin phenotype.

详细描述

Thanks to its excellent negative predictive value, the S100B protein has been defined as a reliable alternative to computed tomography (CT) in the management of traumatic brain injury (TBI). Validated by scientific societies in 2014, the use of this biomarker could reduce the number of cerebral CT scans by nearly one-third in cases of minor TBI.

However, implementation of this blood test in routine clinical practice may present challenges. The extrapolation of findings from S100B studies to the context of Guadeloupe remains uncertain. The commonly accepted threshold of 0.1 μg/L for S100B protein, used to determine the need for CT imaging, has been established based on existing literature. Nevertheless, the study by Abdesselam (Clinical Chemistry 49, No. 5, 2003) suggests that S100B concentrations may vary by ethnic background: higher levels have been observed in individuals of Black phenotype (0.14 ± 0.08 μg/L) compared to those of Asian (0.11 ± 0.08 μg/L) and Caucasian (0.07 ± 0.03 μg/L) phenotypes.

A closer analysis of Abdesselam's data reveals that approximately three-quarters of individuals with a Black phenotype may present physiological S100B levels exceeding 0.1 μg/L. Given that the majority of Guadeloupe's population is of Black phenotype, applying the 0.1 μg/L threshold for CT scan decision-making may lack accuracy for this population. Nonetheless, Abdesselam's study involved a limited sample size (46 individuals of Black ethnicity) and showed high interindividual variability in S100B levels. Further validation is therefore required in Guadeloupe and, more broadly, in Caribbean populations.

The planned study will enroll hospital staff who meet predefined eligibility criteria. Prior to inclusion, eligible individuals will receive an information leaflet and consent form, both explained by a physician or a clinical research nurse. Upon obtaining signed informed consent, each subject will complete an anonymous questionnaire detailing ethnic background, age, sex, and weight. A blood sample will then be collected and sent to the biochemistry laboratory at the University Hospital of Guadeloupe for S100B protein analysis.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

S100B and ethnicity

时间窗: baseline

Level of S100B protein expressed in μg / L, which will be compared according to 3 groups: Afro-Caribbean, Indo-Caribbean and Caucasian.

次要结局

  • S100B and phototypes(baseline)

研究者

发起方
Centre Hospitalier Universitaire de la Guadeloupe
申办方类型
Other
责任方
Sponsor

研究点 (2)

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