AzTrials
AzTrials

s100bPS100B-GNCT06998381

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

An observational study of s100b, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in Guadeloupe.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
s100b
How many people
200 participants
Where
2 sitesGuadeloupe
Study dates
1 Feb 2023to 1 Aug 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Hospital staff of the University Hospital of Guadeloupe or the Basse-Terre Hospital

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Guadeloupe2 sites, 2 recruiting
  • CH de la Basse-Terre

    Basse-Terre, 97109

    Cyrille VAUTRIN, MD, cyrille.vautrin@ch-labasseterre.fr

    Recruiting
  • Chu de La Guadeloupe

    Pointe-à-Pitre, 97159

    Valérie Hamony Soter, +590590934667, valerie.soter@chu-guadeloupe.fr

    Mélanie Petapermal, +590590934667, melanie.petapermal@chu-guadeloupe.fr

    Recruiting

Other trials in Guadeloupe

About this study

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.

Conditions
s100b
Keywords
S100B Protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline

Secondary outcomes (1)
  1. S100B and phototypes

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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study start1 Feb 2023
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06998381
Sponsor's protocol ID
PAP_RIPH2_2020/18
Other IDs
2020-A02605-34
Acronym
PS100B-G
Status last verified
May 2025
First submitted
21 May 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of s100b, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in Guadeloupe.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Valérie Hamony Soter (+590590934677, valerie.soter@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

S100B and ethnicity (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in