NCT06998381

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

May 21, 2025

Last Update Submit

May 30, 2025

Conditions

s100b

Keywords

S100B Protein

Outcome Measures

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.

    baseline

Secondary Outcomes (1)

  • S100B and phototypes

    baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CH de la Basse-Terre

Basse-Terre, 97109, Guadeloupe

RECRUITING

Chu de La Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

RECRUITING

Study Officials

  • Delphine Delta, MD

    CHU de la Guadeloupe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Hamony Soter

CONTACT

+590590934677valerie.soter@chu-guadeloupe.fr

Mélanie Petapermal

CONTACT

+590590934667melanie.petapermal@chu-guadeloupe.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 31, 2025

Study Start

February 1, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Locations

GU(2)