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RecruitingNCT06998381PS100B-GUpdated May 31, 2025

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

An observational study in s100b, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 2 sites in Guadeloupe. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • s100b

Keywords

  • S100B Protein
03

In context

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Hospital staff of the University Hospital of Guadeloupe or the Basse-Terre Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. S100B and ethnicity

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

    Time frame: baseline

Secondary outcomes

  1. S100B and phototypes

    Level of S100B protein expressed in μg / L studied according to the 6 phototypes of Fitzpatrick classification.

    Time frame: baseline

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2023 (actual). Primary completion is estimated for Aug 2025, 30 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2025
First posted
May 31, 2025
StartActual
Feb 1, 2023
Primary completionEst.
Aug 1, 2025
CompletionEst.
Aug 1, 2025
Last update
May 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06998381
Lead sponsor
Centre Hospitalier Universitaire de la Guadeloupe
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Feb 1, 2023
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
May 31, 2025

Study contacts

Valérie Hamony Soter
Contact
valerie.soter@chu-guadeloupe.fr
+590590934677
Mélanie Petapermal
Contact
melanie.petapermal@chu-guadeloupe.fr
+590590934667
Delphine Delta, MD
principal investigator · CHU de la Guadeloupe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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