NCT02683304

Brief Summary

The main objective of this pilot study is to make a first assessment of the discriminating ability of a dosage of S100B protein for differential diagnosis between primary headaches and secondary headaches. For this, the investigators will compare serum S100B protein between two groups of headache patients presenting at the emergency department: 1 group of primary headache patients and 1 group of secondary headache patients. If the difference between the two groups proves potentially discriminating, the investigators will seek to determine the discriminating ability of the S100B protein by calculating the area under the ROC curve. The reference diagnostic will be set at one month across the entire clinical picture and imaging by an expert committee composed of a neurologist, a radiologist and an emergency physician.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 10, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

December 1, 2025

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

January 19, 2016

Last Update Submit

November 24, 2025

Conditions

Headache

Outcome Measures

Primary Outcomes (3)

  • S100B protein level (ng/ml)

    Day 0

  • The presence/absence of a clinically significant anomaly on the MRI scan

    Days 2-4

  • Final diagnostic as established by an expert committee

    The diagnostic posed is either "primary headache" or "secondary headache"

    Month 1

Secondary Outcomes (12)

  • Mortality (yes/no)

    Month 1

  • Length of stay in the emergency department (days)

    Month 1

  • Length of stay in the hospital (days)

    Month 1

  • White blood cell count in cerebral spinal fluid

    Month 1

  • Red blood cell count in cerebral spinal fluid

    Month 1

  • +7 more secondary outcomes

Study Arms (1)

The study population

EXPERIMENTAL

The study population consists of consecutive headache patients (visual analogue scale \> 3) presenting at the emergency department of the Nîmes University Hospital

Biological: Plasma S100B levels at inclusionDevice: Magnetic resonance imaging

Interventions

Plasma S100B levels at inclusionBIOLOGICAL

Patients will have blood drawn to measure plasma S100B levels at inclusion.

The study population
Magnetic resonance imagingDEVICE

If not performed under emergency conditions, patients will have an MRI on days 2-4.

The study population

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient has nontraumatic headache pain with a visual analog scale \> 3

You may not qualify if:

  • The patient is participating in another study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient has a contraindication for magnetic resonance imaging
  • Patients suffering from the following diseases: Alzheimer's disease, multiple sclerosis, Creutzfeldt-Jakob disease, melanoma, trisomy 21.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • Grau-Mercier L, Grandpierre RG, Alonso S, Savey A, Le Floch A, de Oliveira F, Masia T, Jory N, Coisy F, Claret PG. S100B serum level: A relevant biomarker for the management of non-traumatic headaches in emergency care? Am J Emerg Med. 2023 Jun;68:132-137. doi: 10.1016/j.ajem.2023.03.036. Epub 2023 Mar 25.

    PMID: 37001377RESULT

MeSH Terms

Conditions

Headache

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Romain Genre Grandpierre, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

February 17, 2016

Study Start

March 10, 2017

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

December 1, 2025

Record last verified: 2020-07

Locations

FR(1)