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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06998381
Acronym
PS100B-G
Enrollment
200
Registered
2025-05-31
Start date
2023-02-01
Completion date
2025-08-01
Last updated
2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

s100b

Keywords

S100B Protein

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de la Guadeloupe
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

: * Hospital staff of the University Hospital of Guadeloupe or the Hospital of Basse-Terre * Age between 18 and 65 years * Individuals willing to specify their ethnic origin and skin phototype * Individuals affiliated with or beneficiaries of a social security scheme * Informed individuals who have given their voluntary, informed, and written consent

Exclusion criteria

: * Individuals on anticoagulant therapy * Individuals with a personal history of neurological disease * Individuals with a personal history of melanoma * Refusal to participate * Individuals under guardianship, curatorship, or legal protection

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
S100B and phototypesbaselineLevel of S100B protein expressed in μg / L studied according to the 6 phototypes of Fitzpatrick classification.

Countries

Guadeloupe

Contacts

Primary ContactValérie Hamony Soter
valerie.soter@chu-guadeloupe.fr+590590934677
Backup ContactMélanie Petapermal
melanie.petapermal@chu-guadeloupe.fr+590590934667

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026